External ear canal pressure regulation device

ABSTRACT

An external ear canal pressure regulation device including a fluid flow generator, an earpiece having an axial earpiece bore, and a valved conduit fluidicly coupled to the fluid flow generator and the axial earpiece bore, whereby the earpiece has a compliant earpiece external surface configured to sealably engage an external ear canal as a barrier between an external ear canal pressure and an ambient pressure.

This application is the United States National Stage of InternationalPatent Cooperation Treaty Patent Application No. PCT/U.S. Ser. No.14/44159, filed Jun. 25, 2014, which is a continuation of U.S.Non-Provisional Patent Application No. 14/292,469, filed May 30, 2014,and claims the benefit of U.S. Provisional Patent Application No.61/983,865, filed Apr. 24, 2014, U.S. Provisional Patent Application No.61/863,317, filed Aug. 7, 2013, and U.S. Provisional Patent ApplicationNo. 61/841,111, filed Jun. 28, 2013, each hereby incorporated byreference herein.

I. BACKGROUND OF THE INVENTION

Pain or discomfort associated with a disorder, includingneurologically-mediated disorders such as craniofacial pain syndromes orheadache syndromes, may negatively impact the quality of life of thesufferer. In addition to the burden upon the individual, chronicneurological conditions may be a significant strain upon family members,employers, and the healthcare system.

Regarding migraine headaches, concomitant symptoms such as pain, nausea,aura, photophobia, dysesthesias, dizziness, vertigo, and dysequilibriummay represent a significant burden to the population. Epidemiologicalstudies indicate that, in the United States, approximately 18% of womenand 6% of men experience frequent migraine headaches and 2% of thegeneral population suffer from chronic migraine headaches. Additionally,persons suffering with chronic migraine headaches or other headaches ofsimilar severity and disability may be at a significantly greater riskfor depression and attempted suicide. Thus, it is prudent for cliniciansand researchers to continue searching for effective devices and methodsto alleviate the symptoms associated with these disorders or to treatthe disorders.

Standard pharmaceutical therapies for migraine headaches may generallybe prescribed to prevent pain or to relieve pain. The various agentswhich fall under these two broad categories may exhibit a wide range ofeffectiveness and also incur varying degrees of side effects. From theperspective of economics, the expense of these medications may be amajor source of financial burden on the consumer. Moreover, advancedinterventions such as botulinum toxin injections, nerve blockades,neurosurgical alterations, and implanted electrical stimulators maysignificantly increase costs associated with treatment, while subjectingpatients to potential changes in their anatomy and physiology, with noguarantee of complete or permanent symptomatic relief or disorderresolution.

There is a burgeoning field of understanding and applications within theneurosciences which seek to affect positive physiological changes in thenervous system through non-pharmaceutical and non-surgical applications.This field of ‘functional neurology’ views the human nervous system as areceptor driven system, which may be activated and stimulated inspecific ways to produce adaptive, long-term changes through the processof neuroplasticity. This approach to neurorehabilitation utilizes, butnot necessarily exclusively includes, various forms and patterns ofreceptor activation or deactivation to promote positiveneurophysiological adaptations within the central nervous system,including the brain, brainstem, and spinal cord, which may promotephysiological function of associated tissues, organs, and systems.

There would be a substantial advantage in providing a device or methodswhich can generate one or more stimuli which can alleviate one or moresymptoms associated with a disorder, such as craniofacial pain syndromesor headache syndromes, or treat one or more disorders.

II. DISCLOSURE OF THE INVENTION

A broad object of particular embodiments of the invention can be toprovide an external ear canal pressure regulation device including afluid flow generator which generates a fluid flow; a valved conduitfluidicly coupled to the fluid flow generator, the valved conduit havinga first fluid flow conduit interruptible by one or more valves tounidirectionally regulate the fluid flow in the first fluid flowconduit; and an earpiece having an axial earpiece bore whichcommunicates between an earpiece first end and an earpiece second end,the axial earpiece bore fluidicly coupled to the valved conduit oppositethe fluid flow generator, the earpiece having a compliant earpieceexternal surface configured to sealably engage an external ear canal asa barrier between an external ear canal pressure and an ambientpressure.

Another broad object of particular embodiments of the invention can beto provide an external ear canal pressure regulation device having thevalved conduit coupled in a first configuration with the fluid flowgenerator and the earpiece to unidirectionally regulate the fluid flowin a first direction in the first fluid flow conduit such that the fluidflow can egress from the axial earpiece bore of the earpiece toward theexternal ear canal, thereby achieving an external ear canal pressuregreater than the ambient pressure.

Another broad object of particular embodiments of the invention can beto provide an external ear canal pressure regulation device having thevalved conduit coupled in a second configuration with the fluid flowgenerator and the earpiece to unidirectionally regulate the fluid flowin a second direction in the first fluid flow conduit such that thefluid flow can ingress to the axial earpiece bore of the earpiece fromthe external ear canal, thereby achieving an external ear canal pressurelesser than the ambient pressure.

Another broad object of particular embodiments of the invention can beto provide an external ear canal pressure regulation device having avalved conduit which removably couples to the fluid flow generator andthe earpiece. The valved conduit can be coupled in the firstconfiguration with the fluid flow generator and the earpiece tounidirectionally regulate the fluid flow in the first direction in thefirst fluid flow conduit. Additionally, the valved conduit can becoupled in the second configuration with the fluid flow generator andthe earpiece to unidirectionally regulate the fluid flow in the seconddirection in the first fluid flow conduit.

Another broad object of particular embodiments of the invention can beto provide a method of producing an external ear canal pressureregulation device, the method including providing a fluid flow generatorcapable of generating a fluid flow; providing a valved conduit capableof being fluidicly coupled to the fluid flow generator, the valvedconduit having a first fluid flow conduit; providing one or more valvescapable of interrupting the first fluid flow conduit to unidirectionallyregulate the fluid flow in the first fluid flow conduit; and providingan axial earpiece bore, which communicates between an earpiece first endand an earpiece second end of an earpiece, the axial earpiece borecapable of being fluidicly coupled to the valved conduit opposite thefluid flow generator, the earpiece having a compliant earpiece externalsurface configured to sealably engage an external ear canal as a barrierbetween an external ear canal pressure and an ambient pressure.

Another broad object of particular embodiments of the invention can beto provide a method of using an external ear canal pressure regulationdevice, the method including obtaining the external ear canal pressureregulation device including a fluid flow generator which generates afluid flow; a valved conduit fluidicly coupled to the fluid flowgenerator, the valved conduit having a first fluid flow conduitinterruptible by one or more valves to unidirectionally regulate thefluid flow in the first fluid flow conduit; and an earpiece having anaxial earpiece bore which communicates between an earpiece first end andan earpiece second end, the axial earpiece bore fluidicly coupled to thevalved conduit opposite the fluid flow generator, the earpiece having acompliant earpiece external surface configured to sealably engage anexternal ear canal as a barrier between an external ear canal pressureand an ambient pressure; sealably engaging the earpiece external surfaceof the earpiece with the external ear canal; generating the fluid flowbetween the fluid flow generator and the axial earpiece bore; andregulating an external ear canal pressure differential between theexternal ear canal pressure and the ambient pressure.

Naturally, further objects of the invention are disclosed throughoutother areas of the specification, drawings, and claims.

III. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an illustration of a particular embodiment of an external earcanal pressure regulation device sealably engaged with the external earcanal.

FIG. 1B is an illustration of a particular embodiment of an external earcanal pressure regulation device sealably engaged with the external earcanal.

FIG. 2A is a schematic diagram of a particular embodiment of an externalear canal pressure regulation device operable to achieve an external earcanal pressure greater than the ambient pressure.

FIG. 2B is a schematic diagram of a particular embodiment of an externalear canal pressure regulation device operable to achieve an external earcanal pressure lesser than the ambient pressure.

FIG. 3A is a cross sectional view of a particular embodiment of a valvewhich can be utilized in embodiments of the external ear canal pressureregulation device.

FIG. 3B is a cross sectional view of a particular embodiment of a valvewhich can be utilized in embodiments of the external ear canal pressureregulation device.

FIG. 3C is a cross sectional view of a particular embodiment of a valvewhich can be utilized in embodiments of the external ear canal pressureregulation device.

FIG. 3D is a cross sectional view of a particular embodiment of a valvewhich can be utilized in embodiments of the external ear canal pressureregulation device.

FIG. 3E is a cross sectional view of a particular embodiment of a valvewhich can be utilized in embodiments of the external ear canal pressureregulation device.

FIG. 4A is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4B is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4C is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4D is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4E is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4F is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4G is an illustration of the particular embodiment of the externalear canal pressure regulation device shown in FIG. 4F in which anearpiece uncouples from a fluid flow generator and a conduit body.

FIG. 4H is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 4I is an illustration of a particular embodiment of an external earcanal pressure regulation device.

FIG. 5 is a cross sectional view of a particular embodiment of anexternal ear canal pressure regulation device operable to achieve anexternal ear canal pressure greater than the ambient pressure.

FIG. 6 is a cross sectional view of a particular embodiment of anexternal ear canal pressure regulation device operable to achieve anexternal ear canal pressure lesser than the ambient pressure.

FIG. 7 is an exploded view of the particular embodiment of the externalear canal pressure regulation device shown in FIG. 5 operable to achievean external ear canal pressure greater than the ambient pressure.

FIG. 8 is an illustration of a first configuration of an external earcanal pressure regulation device operable to achieve an external earcanal pressure greater than the ambient pressure.

FIG. 9 is an illustration of a method of reconfiguring the firstconfiguration of the external ear canal pressure regulation device shownin FIG. 8 by end-to-end rotation of a conduit body.

FIG. 10 is an illustration of a second configuration of the external earcanal pressure regulation device achieved by end-to-end rotation of aconduit body operable to achieve an external ear canal pressure lesserthan the ambient pressure.

FIG. 11A is an illustration of a first configuration of the external earcanal pressure regulation device having the earpiece external surfacesealably engaged with the external ear canal.

FIG. 11B is an illustration of the first configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal and having thefluid flow generator in a deformed condition generating sufficientpressure within the valved conduit to place a first valve in the opencondition to provide a fluid flow toward the external ear canal toachieve an external ear canal pressure greater than the ambientpressure.

FIG. 11C is an illustration of the first configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal and having thefluid flow generator returning toward a non-deformed condition whichgenerates sufficient pressure to place the first valve in the closedcondition to maintain the external ear canal pressure and place a secondvalve in an open condition to generate a fluid flow from the ambientpressure toward the fluid flow generator.

FIG. 11D is an illustration of the first configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal and having a thirdvalve manually placed in the open condition by operation of a pressurerelief element to generate a fluid flow from the external ear canaltoward the ambient pressure to return the external ear canal pressuretoward the ambient pressure.

FIG. 12A is an illustration of a second configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal.

FIG. 12B is an illustration of the second configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal and having thefluid flow generator in a deformed condition generating sufficientpressure within the valved conduit to place the second valve in the opencondition to provide a fluid flow toward the ambient pressure whilemaintaining the external ear canal pressure at the ambient pressure.

FIG. 12C is an illustration of the second configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal and having thefluid flow generator returning toward a non-deformed condition whichgenerates sufficient pressure to place the first valve in the opencondition and the second valve in the closed condition to generate afluid flow from the external ear canal toward the fluid flow generatorto generate an external ear canal pressure less than the ambientpressure.

FIG. 12D is an illustration of the second configuration of the externalear canal pressure regulation device having the earpiece externalsurface sealably engaged with the external ear canal and having a thirdvalve manually placed in the open condition by operation of a pressurerelief element to generate a fluid flow from the ambient pressure towardthe external ear canal to return the external ear canal pressure towardthe ambient pressure.

FIG. 13A is a top view of a particular embodiment of an external earcanal pressure regulation device.

FIG. 13B is a side view of a particular embodiment of an external earcanal pressure regulation device.

FIG. 13C is an exploded view of a particular embodiment of an externalear canal pressure regulation device.

FIG. 13D is an exploded view of a particular embodiment of an externalear canal pressure regulation device.

FIG. 13E is a cross sectional view of the particular embodiment of theexternal ear canal pressure regulation device shown in FIG. 13A operableto generate an external ear canal pressure greater than the ambientpressure.

FIG. 13F is a cross sectional view of a particular embodiment of theexternal ear canal pressure regulation device operable to generate anexternal ear canal pressure lesser than the ambient pressure.

FIG. 14A is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generatorgenerates and maintains a substantially invariant external ear canalpressure greater than the ambient pressure at a maximum pressure for atime period and by operation of the pressure relief element, theexternal ear canal pressure returns toward the ambient pressure.

FIG. 14B is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure greater than the ambient pressurewith the pressure wave being a sine wave having smooth repetitiveperiodic oscillations.

FIG. 14C is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure greater than the ambient pressurewith the pressure wave being a truncated wave in which the apex of thepressure wave has a constant pressure over a time period.

FIG. 14D is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure greater than the ambient pressurewith the pressure wave being a triangle wave having linear leading andtrailing edges.

FIG. 14E is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure greater than the ambient pressurewith the pressure wave being a sawtooth wave in which the leading edgechanges pressure over a time period which is greater than the timeperiod in which the trailing edge changes pressure.

FIG. 14F is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure greater than the ambient pressurewith the pressure wave being a truncated wave in which the apex of thepressure wave has a constant pressure over a time period.

FIG. 14G is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the first configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure greater than the ambient pressure.

FIG. 15A is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generatorgenerates and maintains a substantially invariant external ear canalpressure lesser than the ambient pressure at a maximum pressure for atime period and by operation of the pressure relief element, theexternal ear canal pressure returns toward the ambient pressure.

FIG. 15B is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure lesser than the ambient pressurewith the pressure wave being a sine wave having smooth repetitiveperiodic oscillations.

FIG. 15C is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure lesser than the ambient pressurewith the pressure wave being a truncated wave in which the apex of thepressure wave has a constant pressure over a time period.

FIG. 15D is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure lesser than the ambient pressurewith the pressure wave being a triangle wave having linear leading andtrailing edges.

FIG. 15E is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure lesser than the ambient pressurewith the pressure wave being a reverse sawtooth wave in which theleading edge changes pressure over a time period which is lesser thanthe time period in which the trailing edge changes pressure.

FIG. 15F is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure lesser than the ambient pressurewith the pressure wave being a truncated wave in which the apex of thepressure wave has a constant pressure over a time period.

FIG. 15G is a plot of the external ear canal pressure relative to theambient pressure achieved over a time period which represents a methodof use of the second configuration of the external ear canal pressureregulation device in which operation of the fluid flow generator withintermittent operation of the pressure relief element generates apulsatile external ear canal pressure lesser than the ambient pressure.

IV. MODE(S) FOR CARRYING OUT THE INVENTION

Now referring primarily to FIG. 1A and FIG. 1B, which illustrateparticular methods of using an external ear canal pressure regulationdevice (1) including one or more of: a fluid flow generator (2), anearpiece (3) having an axial earpiece bore (4), and a valved conduit (5)fluidicly coupled to the fluid flow generator (2) and the axial earpiecebore (4). The method of use can include sealably engaging an externalear canal (6) with an earpiece external surface (7) of the earpiece (3),generating a fluid flow (8) between the fluid flow generator (2) and theaxial earpiece bore (4), and regulating a pressure differential (9)between an external ear canal pressure (10) and an ambient pressure (11)to alleviate one or more disorder symptoms or treat one or moredisorders.

The term “pressure differential” for the purposes of this inventionmeans the difference in pressure between two locations.

The term “pressure differential amplitude” for the purposes of thisinvention means the numerical value of the difference in pressurebetween two locations. The pressure differential amplitude (59) can beexpressed as a number without a sign (positive or negative), regardlessof whether the pressure is greater or lesser in the first locationrelative to the second location. As an illustrative example, an externalear canal pressure (10) of +50 kilopascals above the ambient pressure(11) and an external ear canal pressure (10) of −50 kilopascals belowthe ambient pressure (11) can both have a pressure differentialamplitude (59) of 50 kilopascals.

The term “external ear canal pressure” for the purposes of thisinvention means forces exerted within the external ear canal (6) and,without limitation to the breadth of the foregoing, means forces exertedwithin the external ear canal (6) by a fluid volume (12), a pre-selectedfluid volume (12), or a fluid flow (8) delivered to or generated in theexternal ear canal (6) by operation of the external ear canal pressureregulation device (1).

The term “ambient pressure” for the purposes of this invention meansforces exerted external to the external ear canal (6) in the ambientenvironment and, without limitation to the breadth of the foregoing,means forces exerted on the earpiece (3) having the earpiece externalsurface (7) sealably engaged with the external ear canal (6), as hereindescribed.

The term “pre-selected” for the purposes of this invention means aparameter, such as a fluid volume (12) or a pressure differentialamplitude (59) which has been determined prior to administration, forexample by a user (23) of the external ear canal pressure regulationdevice (1), for delivery to, generation in, or administration to theexternal ear canal (6) by operation of the external ear canal pressureregulation device (1) and subsequently delivered to, generated in, oradministered to the external ear canal (6) by operation of the externalear canal pressure regulation device (1). For example, a pre-selectedfluid volume (12) of 10 milliliters can be prior selected for deliveryto the external ear canal (6) by operation of the external ear canalpressure regulation device (1) and subsequently, the pre-selected fluidvolume (12) of 10 milliliters can be delivered to the external ear canal(6) by operation of the external ear canal pressure regulation device(1).

The term “symptom” for the purposes of this invention means anydiscomfort or combination of discomforts associated with a disorder.Without limiting the breadth of the foregoing, symptoms can include:dizziness; vertigo; nausea; imbalance; paresthesia; dysesthesia;sensitivity to light; sensitivity to odor; sensitivity to sound;anxiety; sleeplessness; irritability; fatigue; loss of appetite; blurredvision; gut disturbances; acute pain or chronic pain of varyingcharacteristics including but not limited to throbbing, tearing, sharp,dull, deep, lancinating, burning, aching, stabbing, intense,lightning-like, sense of swelling, or tingling; or the like; orcombinations thereof.

The term “disorder” for the purposes of this invention means a physicalor mental condition which may not be normal or healthy. Without limitingthe breadth of the foregoing, a disorder can include: neuropathiccraniofacial pain syndromes such as neuralgias, for example trigeminalneuralgia; temporomandibular joint syndrome; headache syndromes such asmigraine headaches, chronic daily headaches, cluster headaches, muscletension headaches, post-traumatic headaches, or chronic paroxysmalhemicranias; endolymphatic hydrops; vertigo; tinnitus; syndromesresulting from brain injury; syndromes resulting from impairedneurologic function, including cognitive disorders such as attentiondeficit disorder, emotional disorders such as anxiety disorders, orseizure disorders; phantom limb; middle ear disorders; inner eardisorders; or the like, or combinations thereof.

Now referring primarily to FIG. 2A and FIG. 2B, the fluid flow generator(2) can have any of a wide variety of numerous configurations capable ofgenerating a fluid flow (8) between the fluid flow generator (2) and theaxial earpiece bore (4). As to particular embodiments, the fluid flowgenerator (2) can include a volumetrically adjustable element (13)capable of adjusting between a greater volume and a lesser volume. As anillustrative example, adjusting the volumetrically adjustable element(13) from a greater volume to a lesser volume can generate a fluid flow(8) away from the fluid flow generator (2) whereas adjusting thevolumetrically adjustable element (13) from a lesser volume to a greatervolume can generate a fluid flow (8) toward the fluid flow generator(2).

As to particular embodiments, the fluid flow generator (2) can include abladder (14) or a diaphragm (15) which has a resiliently flexible wall(16) having a wall external surface (17) and a wall internal surface(18). The wall external surface (17) can be configured in any mannerwhich allows deformation of the resiliently flexible wall (16) (as shownin the examples of FIG. 11A through FIG. 12D and FIG. 13A through FIG.13F). The wall internal surface (18) can define an internal volume (19)(whether in whole or in part as an assembly with the valved conduit(5)). The resiliently flexible wall (16) in a deformed condition (20)(as shown in the examples of FIG. 11B and FIG. 12B) can decrease theinternal volume (19), and in return toward a non-deformed condition (21)(as shown in the example of FIG. 11C and FIG. 12C), can increase theinternal volume (19). The change in the internal volume (19) cangenerate a fluid flow (8) between the fluid flow generator (2) and theaxial earpiece bore (4), which can be regulated by the valved conduit(5). As to particular embodiments, the bladder (14) or the diaphragm(15) can have an internal volume (19) in the non-deformed condition (21)which can be insufficient upon complete reduction in internal volume(19) to the deformed condition (20) to generate a fluid flow (8) or anamount of pressure (22) capable of causing discomfort to a user (23) ofthe external ear canal pressure regulation device (1) or injury to anauditory meatus (24) or a tympanic membrane (25).

As to other particular embodiments, the fluid flow generator (2) caninclude a positive displacement pump (26) in which a piston (27)reciprocally operates in a barrel (28) (as shown in the illustrativeexample of FIG. 4C) to adjust a barrel internal volume between a lesservolume and a greater volume. The reciprocal motion of the piston (27)within the barrel (28) can generate a fluid flow (8) between the fluidflow generator (2) and the axial earpiece bore (4), which can beregulated by the valved conduit (5). As to particular embodiments, thebarrel (28) can have a barrel internal volume which can be insufficientupon complete reduction in barrel internal volume by travel of thepiston (27) within the barrel (28) to generate a fluid flow (8) or anamount of pressure (22) capable of causing discomfort to the user (23)of the external ear canal pressure regulation device (1) or injury tothe auditory meatus (24) or the tympanic membrane (25).

The fluid flow generator (2) can be configured to generate a fluid flow(8) in the valved conduit (5) between the fluid flow generator (2) andthe axial earpiece bore (4), whereby the fluid flow (8) can have a fluidvolume (12) typically in a range of between 0 milliliters to about 20milliliters; however, embodiments can have a lesser or greater fluidvolume (12) depending upon the application. As to particularembodiments, the fluid volume (12) can be a pre-selected fluid volume(12), which can be selected from one or more of the group including orconsisting of: between 0 milliliters to about 2 milliliters, betweenabout 1 milliliter to about 3 milliliters, between about 2 millilitersto about 4 milliliters, between about 3 milliliters to about 5milliliters, between about 4 milliliters to about 6 milliliters, betweenabout 5 milliliters to about 7 milliliters, between about 6 millilitersto about 8 milliliters, between about 7 milliliters to about 9milliliters, between about 8 milliliters to about 10 milliliters,between about 9 milliliters to about 11 milliliters, between about 10milliliters to about 12 milliliters, between about 11 milliliters toabout 13 milliliters, between about 12 milliliters to about 14milliliters, between about 13 milliliters to about 15 milliliters,between about 14 milliliters to about 16 milliliters, between about 15milliliters to about 17 milliliters, between about 16 milliliters toabout 18 milliliters, between about 17 milliliters to about 19milliliters, and between about 18 milliliters to about 20 milliliters.

One or more pre-selected fluid volumes (12) can be generated with theexternal ear canal pressure regulation device (1) depending upon themethod of use, which can be further influenced by factors such as user(23) anatomy, physiology, or biochemistry of the auditory meatus (24);disorder symptom targeted for alleviation; disorder targeted fortreatment; observable effect(s) of using one or more pre-selected fluidvolumes (12) in a particular method of using the external ear canalpressure regulation device (1); or the like; or combinations thereof;but not so much as to cause discomfort to the user (23) or injury to theauditory meatus (24) or the tympanic membrane (25).

Again referring primarily to FIGS. 2A and 2B, the earpiece (3) can havea compliant earpiece external surface (7) configured to insert into theexternal ear canal (6) of the auditory meatus (24), thus acting as abarrier between the external ear canal pressure (10) and the ambientpressure (11). Embodiments of the earpiece (3) can be configured tosufficiently sealably engage with the external ear canal (6) to resistaxial or lateral displacement in view of normal anatomical variations ofthe external ear canal (6) over a normal range of operating temperaturesof between about 20° C. (about 68° F.) to about 50° C. (about 122° F.)and allow generation and maintenance of a normal range of operatingpressures of between about negative 50 kilopascals (−50 kPa) below theambient pressure (11) to about positive 50 kilopascals (+50 kPa) abovethe ambient pressure (11).

The earpiece (3) of the external ear canal pressure regulation device(1) can be formed from a compliant material which can compressiblydeform upon engagement with the external ear canal (6), thereby allowingthe earpiece (3) to sealably conform to the external ear canal (6). Asto these particular embodiments, the earpiece (3) can be formed, molded,three-dimensionally printed, or otherwise fabricated from any of anumerous and wide variety of materials capable of sealable engagementwith the external ear canal (6), including or consisting of: a silicone,a foam (including polyurethane foam), a polyvinylsiloxane, a lowdurometer elastomer, or the like, or combinations thereof.

As to particular embodiments, the earpiece (3) can be formed from onematerial, for example a lesser durometer elastomer. As to otherparticular embodiments, the earpiece (3) can be formed from a pluralityof layers, for example an inner core layer having a greater durometersurrounded by an outer layer having a lesser durometer or an inner corelayer having a lesser durometer surrounded by an outer layer having agreater durometer. As to yet other particular embodiments, a flexibleearpiece wall can define a hollow inner space of the earpiece (3),whereby the flexible earpiece wall can deform to allow the earpieceexternal surface (7) to sealably conform to the external ear canal (6).

As to particular embodiments, a portion of the earpiece external surface(7) can inwardly taper approaching an earpiece second end (29) (as shownin the examples of FIG. 4A through FIG. 4D). As an illustrative exampleof particular embodiments of this configuration, the earpiece externalsurface (7) can be configured in the general form of a truncated coneinwardly tapering approaching the earpiece second end (29) (as shown inthe examples of FIG. 4E through FIG. 4G).

The earpiece external surface (7) can further include a plurality ofcircumferential ribs (30) disposed in spaced apart relation between anearpiece first end (31) and the earpiece second end (29). Each of theplurality of circumferential ribs (30) can extend from the earpieceexternal surface (7) a substantially uniform height; however, as tothose embodiments of the earpiece external surface (7) having a conicalconfiguration, the plurality of circumferential ribs (30) can have a ribdiameter (32) which decreases approaching the earpiece second end (29)(as shown in example of FIG. 4H). As an illustrative example, the ribdiameter (32) of a first circumferential rib (33) proximate the earpiecefirst end (31) can be about seven centimeters and the rib diameter (32)of a last circumferential rib (34) proximate the earpiece second end(29) can be about four centimeters, with the circumferential ribs (30)disposed between the first circumferential rib (33) and the lastcircumferential rib (34) having rib diameters (32) which respectivelydecrease from the first circumferential rib (33) to the lastcircumferential rib (34). However, embodiments need not necessarily beso limited and the plurality of circumferential ribs (30) can beconfigured in any of a wide variety of numerous configurations adaptedto insert into and sealably engage with the external ear canal (6), thusacting as a barrier between the external ear canal pressure (10) and theambient pressure (11).

The earpiece external surface (7) can remain sealably engaged with theexternal ear canal (6) by frictional forces between the earpieceexternal surface (7) and the external ear canal (6). As to particularembodiments, the earpiece external surface (7) can remain engaged withthe external ear canal (6) by forcible urging against the external earcanal pressure regulation device (1) during normal operation. As toother particular embodiments, a restraint element coupled to theexternal ear canal pressure regulation device (1) can be worn about theear (35) or the head (36) to assist with retention of the earpiece (3)within the external ear canal (6).

Again referring primarily to FIG. 2A and FIG. 2B, the earpiece (3) canhave an axial earpiece bore (4) which communicates between the earpiecefirst end (31) and the earpiece second end (29). The axial earpiece bore(4) proximate the earpiece first end (31) can be fluidicly coupled to avalved conduit (5) and configured to allow a fluid flow (8) between theearpiece first and second ends (31)(29).

Now referring primarily to FIG. 5 and FIG. 6, the earpiece (3) canfurther include a tubular bolt (37) disposed about the axial earpiecebore (4). The tubular bolt (37) can communicate, whether in whole or inpart, between the earpiece first end (31) and the earpiece second end(29), providing a bolt bore (38) communicating, whether in whole or inpart, between the earpiece first end (31) and the earpiece second end(29). The tubular bolt (37) can be sufficiently rigid to reduce orprevent deformation of the axial earpiece bore (4) upon sealableengagement of the earpiece external surface (7) with the external earcanal (6) to maintain sufficient fluid flow (8) within the axialearpiece bore (4) during normal use as described above, for example overa normal range of operating temperatures and a normal range of operatingpressures.

The tubular bolt (37) can further include a bolt external surface (39)dimensioned for removable insertion into the axial earpiece bore (4),providing an adequate fluid-tight seal to maintain sufficient fluid flow(8) within the axial earpiece bore (4) during normal use as describedabove, for example over a normal range of operating temperatures and anormal range of operating pressures. As to particular embodiments, thebolt external surface (39) can further include a plurality ofcircumferential barbs spaced apart along the bolt external surface (39)to assist in retaining the tubular bolt (37) within the axial earpiecebore (4) and in providing the fluid-tight seal.

As to particular embodiments including a discrete tubular bolt (37), theearpiece (3) and the tubular bolt (37) can be provided as a one-piececonstruct having the earpiece (3) molded or formed about the tubularbolt (37). As to other particular embodiments, the earpiece (3) can beformed or molded to provide increasing rigidity approaching the axialearpiece bore (4). However, embodiments need not necessarily be solimited, as any of a wide variety of numerous structures known to thoseof ordinary skill in the art can be utilized to provide a tubular bolt(37) in fluid-tight relation with the axial earpiece bore (4).

Now referring primarily to FIG. 7 through FIG. 10, the external earcanal pressure regulation device (1) can include a valved conduit (5)fluidicly coupled to the fluid flow generator (2) and the axial earpiecebore (4). As to particular embodiments, the valved conduit (5) can beincluded in a conduit body (41) having a configuration which removablycouples to the fluid flow generator (2) and the earpiece (3), wherebythe fluid flow generator (2) and the earpiece (3) can be removablycoupled to either one of a conduit body first end (42) or a conduit bodysecond end (43). The releasably couplable surfaces (44) of the fluidflow generator (2), the earpiece (3), the conduit body first end (42),and the conduit body second end (43) can have sufficiently similarconfigurations (as shown in the example of FIG. 7) to allow the fluidflow generator (2) and the earpiece (3) to releasable couple to eitherof the conduit body first end (42) or the conduit body second end (43)depending upon whether the valved conduit (5) operates to achieve apressure differential (9) having the external ear canal pressure (10)greater than the ambient pressure (11) (as shown in the example of FIG.5) or whether the valved conduit (5) operates to achieve a pressuredifferential (9) having the external ear canal pressure (10) lesser thanambient the pressure (11) (as shown in the example of FIG. 6).

The releasably couplable surfaces (44) of the fluid flow generator (2),the earpiece (3), the conduit body first end (42), and the conduit bodysecond end (43) can matably engage. As an illustrative example, thereleasably couplable surfaces (44) can be configured as rotatablymatable spiral threads. However, embodiments need not necessarily be solimited and can have releasably couplable surfaces (44) configured inany of a wide variety of numerous manners which allow the conduit body(41) including the valved conduit (5) to be positioned in a firstconfiguration (45) to operationally achieve a pressure differential (9)having the external ear canal pressure (10) greater than the ambientpressure (11) (as shown in the example of FIG. 5) and further allows theconduit body (41) including the valved conduit (5) to be positioned in asecond configuration (46) to operationally achieve a pressuredifferential (9) having the external ear canal pressure (10) lesser thanthe ambient pressure (11) (as shown in the example of FIG. 6).

As an illustrative example, the conduit body (41) including the valvedconduit (5) can be positioned in the first configuration (45) byremovably coupling the conduit body first end (42) with the fluid flowgenerator (2) and removably coupling the conduit body second end (43)with the earpiece (3) (as shown in the example of FIG. 8). As such, thefluid flow (8) can be regulated in a first direction (47) in the valvedconduit (8) to operationally achieve a pressure differential (9) havingthe external ear canal pressure (10) greater than the ambient pressure(11) (as shown in the example of FIG. 5).

As to particular embodiments, the fluid flow generator (2) can beremoved from the conduit body first end (42) and the earpiece (3) can beremoved from the conduit body second end (43) to disassemble the firstconfiguration (45). The conduit body (41) can be rotated without anystructural alteration to reverse orientation of the conduit body firstand second ends (42)(43) (as shown in the example of FIG. 9). The valvedconduit (5) can be positioned in the second configuration (46) byremovably coupling the conduit body first end (42) with the earpiece (3)and removably coupling the conduit body second end (43) with the fluidflow generator (2) (as shown in the example of FIG. 10). As such, thefluid flow (8) can be regulated in a second direction (48) in the valvedconduit (5) to operationally achieve a pressure differential (9) havingthe external ear canal pressure (10) lesser than the ambient pressure(11) (as shown in the example of FIG. 6).

Now referring primarily to FIG. 2A, FIG. 2B, FIG. 5, and FIG. 6, thevalved conduit (5) can include a first fluid flow conduit (49)communicating between a first fluid flow conduit first end (50) and afirst fluid flow conduit second end (51). As to the particularembodiments of the external ear canal pressure regulation device (1)described herein, the first fluid flow conduit first end (50)communicates with the fluid flow generator (2) and the first fluid flowconduit second end (51) communicates with the axial earpiece bore (4) ofthe earpiece (3), whether the conduit body (41) is positioned in thefirst configuration (45) or the second configuration (46).

The first fluid flow conduit (49) can be interruptible by a first valve(52) to unidirectionally regulate the fluid flow (8) between the firstfluid flow conduit first and second ends (50)(51) and, correspondingly,between the fluid flow generator (2) and the axial earpiece bore (4). Inthe first configuration (45) described above, the fluid flow generator(2) can be sealably engaged with the first fluid flow conduit first end(50) and the axial earpiece bore (4) can be sealably engaged with thefirst fluid flow conduit second end (51) to unidirectionally regulatethe fluid flow (8) in the first direction (47) from the fluid flowgenerator (2) toward the axial earpiece bore (4). As such, the externalear canal pressure regulation device (1) sealably engaged with anexternal ear canal (6) can operationally achieve a pressure differential(9) having the external ear canal pressure (10) greater than the ambientpressure (11) by transferring a fluid volume (12) from the fluid flowgenerator (2) toward the external ear canal (6). In the secondconfiguration (46) described above, the fluid flow generator (2) can besealably engaged with the first fluid flow conduit first end (50) andthe axial earpiece bore (4) can be sealably engaged with the first fluidflow conduit second end (51) to unidirectionally regulate the fluid flow(8) in the second direction (48) from the axial earpiece bore (4) towardthe fluid flow generator (2). As such, the external ear canal pressureregulation device (1) sealably engaged with an external ear canal (6)can operationally achieve a pressure differential (9) having theexternal ear canal pressure (10) lesser than the ambient pressure (11)by transferring a fluid volume (12) from the external ear canal (6)toward the fluid flow generator (2).

Again referring primarily to FIG. 2A, FIG. 2B, FIG. 5, and FIG. 6, thefirst valve (52) can divide the first fluid flow conduit (49) into afirst portion (53) proximate the first fluid flow conduit first end (50)and, correspondingly, proximate the fluid flow generator (2), and asecond portion (54) proximate the first flow fluid conduit second end(51), and, correspondingly, proximate the axial earpiece bore (4) of theearpiece (3). As to particular embodiments, the valved conduit (5) canfurther include a second fluid flow conduit (55) fluidicly coupledbetween the first portion (53) of the first fluid flow conduit (49) andthe ambient pressure (11). As to the particular embodiments of theexternal ear canal pressure regulation device (1) described herein, thesecond fluid flow conduit (55) fluidicly couples to the first portion(53) of the first fluid flow conduit (49) proximate the fluid flowgenerator (2), whether the conduit body (41) is positioned in the firstconfiguration (45) or the second configuration (46). The second fluidflow conduit (55) can be interruptible by a second valve (56) tounidirectionally regulate the fluid flow (8) in the second fluid flowconduit (55).

Now referring primarily to FIG. 2A and FIG. 5, as to particularembodiments of the first configuration (45) having a fluid flowgenerator (2) which includes a volumetrically adjustable element (13)having an internal volume (19) bounded by a resiliently flexible wall(16), a deformed condition (20) of the resiliently flexible wall (16)can decrease the internal volume (19) to generate a fluid flow (8) inthe first direction (47) in the first fluid flow conduit (49) from thefluid flow generator (2) toward the axial earpiece bore (4) of theearpiece (3), whereby the first valve (52) and the second valve (56)unidirectionally regulate the fluid flow (8) to egress from the axialearpiece bore (4). As such, the external ear canal pressure regulationdevice (1) sealably engaged with an external ear canal (6) canoperationally achieve a pressure differential (9) having the externalear canal pressure (10) greater than the ambient pressure (11) bytransferring a fluid volume (12) from the fluid flow generator (2)toward the external ear canal (6).

The resiliently flexible wall (16) of the volumetrically adjustableelement (13) can return to a non-deformed condition (21) which canincrease the internal volume (19) to generate a fluid flow (8) in thesecond fluid flow conduit (55), whereby the second valve (56)unidirectionally regulates the fluid flow (8) to ingress from an ambientpressure (11) toward the fluid flow generator (2). The first valve (52)can interrupt the fluid flow (8) in the first fluid flow conduit (49)from the axial earpiece bore (4) toward the fluid flow generator (2).Embodiments of the external ear canal pressure regulation device (1)sealably engaged with an external ear canal (6) can operationallymaintain a pressure differential (9) in which the external ear canalpressure (10) can be maintained greater than the ambient pressure (11)and concurrently transfer a fluid volume (12) from the ambient pressure(11) toward the fluid flow generator (2) to return the resilientlyflexible wall (16) of the volumetrically adjustable element (13) towardthe non-deformed condition (21).

Now referring primarily to FIG. 2B and FIG. 6, as to particularembodiments of the second configuration (46) having a fluid flowgenerator (2) which includes a volumetrically adjustable element (13)having an internal volume (19) bounded by a resiliently flexible wall(16), a deformed condition (20) of the resiliently flexible wall (16)can decrease the internal volume (19) to generate a fluid flow (8) inthe second fluid flow conduit (55) from the fluid flow generator (2)toward the ambient pressure (11), whereby the first valve (52) and thesecond valve (56) unidirectionally regulate the fluid flow (8) to egressfrom the second fluid flow conduit (55) toward the ambient pressure(11).

The resiliently flexible wall (16) of the volumetrically adjustableelement (13) can return to a non-deformed condition (21) which canincrease the internal volume (19) to generate a fluid flow (8) in thesecond direction (48) in the first fluid flow conduit (49), whereby thefirst valve (52) unidirectionally regulates the fluid flow (8) toingress from the axial earpiece bore (4) of the earpiece (3) toward thefluid flow generator (2). The second valve (56) can interrupt the fluidflow (8) in the second fluid flow conduit (55) from the ambient pressure(11) toward the fluid flow generator (2). As such, the external earcanal pressure regulation device (1) sealably engaged with an externalear canal (6) can operationally achieve and maintain a pressuredifferential (9) in which the external ear canal pressure (10) can bemaintained lesser than the ambient pressure (11) and concurrentlytransfer a fluid volume (12) from the external ear canal (6) toward thefluid flow generator (2) to return the resiliently flexible wall (16) ofthe volumetrically adjustable element (13) toward the non-deformedcondition (21).

Now referring primarily to FIG. 2A, FIG. 2B, FIG. 5, and FIG. 6, as toparticular embodiments, the valved conduit (5) can further include athird fluid flow conduit (57) fluidicly coupled between the secondportion (54) of the first fluid flow conduit (49) and the ambientpressure (11). As to the particular embodiments of the external earcanal pressure regulation device (1) described herein, the third fluidflow conduit (57) fluidicly couples to the second portion (54) of thefirst fluid flow conduit (49) proximate the axial earpiece bore (4),whether the conduit body (41) is positioned in the first configuration(45) or the second configuration (46).

The third fluid flow conduit (57) can be interruptible by a third valve(58) to unidirectionally regulate the fluid flow (8) in the third fluidflow conduit (57). As to particular embodiments, the third valve (58)can regulate the fluid flow (8) to egress toward the ambient pressure(11) from the third fluid flow conduit (57). As to other particularembodiments, the third valve (58) can regulate the fluid flow (8) toingress from the ambient pressure (11) toward the third fluid flowconduit (57).

As to particular embodiments, the third valve (58) can interrupt thefluid flow (8) within the third fluid flow conduit (57) until a pressuredifferential (9) between the second portion (54) of the first fluid flowconduit (49) and the ambient pressure (11) exceeds a pre-selectedpressure differential (9) having a pressure differential amplitude (59)typically in a range of between 0 kilopascals to about 50 kilopascals;however embodiments can have a lesser or greater pre-selected pressuredifferential amplitude (59) depending upon the application. As toparticular embodiments, the pre-selected pressure differential amplitude(59) can be selected from the group including of consisting of: between0 kilopascals to about 5 kilopascals, between about 2.5 kilopascals toabout 7.5 kilopascals, between about 5 kilopascals to about 10kilopascals, between about 7.5 kilopascals to about 12.5 kilopascals,between about 10 kilopascals to about 15 kilopascals, between about 12.5kilopascals to about 17.5 kilopascals, between about 15 kilopascals toabout 20 kilopascals, between about 17.5 kilopascals to about 22.5kilopascals, between about 20 kilopascals to about 25 kilopascals,between about 22.5 kilopascals to about 27.5 kilopascals, between about25 kilopascals to about 30 kilopascals, between about 27.5 kilopascalsto about 32.5 kilopascals, between about 30 kilopascals to about 35kilopascals, between about 32.5 kilopascals to about 37.5 kilopascals,between about 35 kilopascals to about 40 kilopascals, between about 37.5kilopascals to about 42.5 kilopascals, between about 40 kilopascals toabout 45 kilopascals, between about 42.5 kilopascals to about 47.5kilopascals, and between about 45 kilopascals to about 50 kilopascals.

One or more pre-selected pressure differential amplitudes (59) can begenerated with the external ear canal pressure regulation device (1)depending upon the method of use, which can be further influenced byfactors such as user (23) anatomy, physiology, or biochemistry of theauditory meatus (24); disorder symptom targeted for alleviation;disorder targeted for treatment; observable effect(s) of using one ormore pre-selected pressure differential amplitudes (59) in a particularmethod of using the external ear canal pressure regulation device (1);or the like; or combinations thereof; but not so much as to causediscomfort to the user (23) or injury to the auditory meatus (24) or thetympanic membrane (25).

Now referring primarily to FIG. 2A and FIG. 2B, the valved conduit (5)can include a fluid flow manifold (60) interruptible by operation of oneor more valves (61), for example the first valve (52), the second value(56), the third value (58), or additional valves (61) to correspondinglyalter the configuration of a manifold fluid flow path (62) within thefluid flow manifold (60) to regulate the fluid flow (8) within the fluidflow manifold (60). While the figures schematically illustrateparticular configurations of the fluid flow manifold (60) whichcorrespondingly define particular configurations of the manifold fluidflow path (62), these embodiments need not necessarily be so limited inregard to the configuration of the fluid flow manifold (60) or themanifold fluid flow path (62) of the valved conduit (5) and embodimentscan include any of a wide variety of numerous configurations which canfluidicly couple the first, second, or third fluid flow conduits(49)(55)(57) as above described (or additional fluid flow conduits)whether as a plurality of discrete conduits, a one-piece manifold, ordefined by a conduit body (41) whether formed, molded,three-dimensionally printed, or otherwise fabricated as a one-piececonstruct or assembled from a plurality of pieces into which the first,second, or third valves (52)(56)(58) (or additional valves (61)) can bedisposed, assembled, or otherwise coupled to generate the valved conduit(5) and without limitation to the breadth of the foregoing, include theconfigurations of the conduit body (41) shown in illustrative examplesof FIG. 4A through FIG. 6, which can be injection molded as a one-piececonduit body (41) about or which can receive the first, second, or thirdvalves (52)(56)(58) (or additional valves).

Now referring primarily to FIG. 3A through FIG. 3E, the first, second,or third valves (52)(56)(58) schematically illustrated in FIG. 2A andFIG. 2B can have any type of valve configuration capable of regulating afluid flow (8) as described herein and without limitation to the breadthof the foregoing, can include a spring-loaded ball check valve (63) (asshown in the example of FIG. 3C), a flapper valve (64) having a hinge(94) (as shown in the example of FIG. 3B), a spring-loaded valve havinga seat and seatable deformable circular lip (65) (as shown in theexample of FIG. 3A), an umbrella valve (66) (as shown in the example ofFIG. 3D), a duckbill valve (67) (as shown in the example of FIG. 3E), orother valves (61) which can operate between a closed condition (68) andan open condition (69) to unidirectionally regulate fluid flow (8) in apre-selected range.

As to particular embodiments, each of the first, second, or third valves(52)(56)(58) can operate between the closed condition (68), which can besubstantially leak-tight to backward flow and substantially leak-tightto forward fluid flow (8) up to about a 50 kilopascal pressuredifferential amplitude (59) on opposed sides of the valve (61), and theopen condition (69), which can have a forward flow in the range of about0.2 milliliters per second to about 20 milliliters per second. As toparticular embodiments, the pressure differential (9) between opposedsides of a valve (61) or the forward fluid flow (8) in the opencondition (69) of a valve (61) can be adjusted by the configuration ofthe valve (61), the unrestricted cross-sectional area of the manifoldfluid flow path (62), or the like, or combinations thereof.Additionally, while examples of the external ear canal pressureregulation device (1) disclosed can generate a pressure differentialamplitude (59) between the external ear canal pressure (10) and theambient pressure (11) of up to 50 kilopascals, these examples are notintended to teach or suggest that all embodiments of the external earcanal pressure regulation device (1) necessarily achieve this pressuredifferential amplitude (59) between the external ear canal pressure (10)and the ambient pressure (11). Rather, particular embodiments of theexternal ear canal pressure regulation device (1) can be configured toachieve a pressure differential (9) between the external ear canalpressure (10) and the ambient pressure (11) based on being effective toalleviate one or more disorder symptoms, for exampleneurologically-mediated pain, or treat one or more disorders, forexample craniofacial pain syndromes or headache syndromes.

Now referring primarily to FIG. 5, FIG. 6, and FIG. 11A through FIG.12D, as to particular embodiments, a valve (61) can be operativelycoupled to a pressure relief element (70) configured to allow manualoperation of the valve (61) between the closed condition (68) and theopen condition (69). As an illustrative example, a pressure reliefelement (70) can be operable to allow the external ear canal pressure(10) to return toward the ambient pressure (11), whether from anexternal ear canal pressure (10) greater than the ambient pressure (11)or an external ear canal pressure (10) lesser than the ambient pressure(11). As to particular embodiments, a pressure relief element (70) canbe operable to allow a fluid volume (12) to egress from a portion of thevalved conduit (5) toward the ambient pressure (11) or ingress from theambient pressure (11) toward a portion of the valved conduit (5) uponreaching or exceeding a pre-selected threshold external ear canalpressure (10), thereby reducing the risk of discomfort to a user (23) orinjury to the auditory meatus (24) or the tympanic membrane (25).

As to particular embodiments, the pressure relief element (70) can beconfigured to extend a sufficient distance outward from the conduit body(41) to allow gripping engagement by a user (23). As to other particularembodiments, the pressure relief element (70) can be configured as aresiliently flexible portion of the conduit body (41) which can flexupon pressing engagement, placing the valve (61) in the open condition(69). Upon disengagement of the pressure relief element (70), the valve(61) can return to the closed condition (68).

Again referring primarily to FIG. 5, FIG. 6, and FIG. 11A through FIG.12D, as to particular embodiments, a second valve pressure reliefelement (71) can be coupled to the second valve (56) and a third valvepressure relief element (72) can be coupled to the third valve (58).Each of the second and third valve pressure relief elements (71)(72) canbe manually operable to correspondingly generate a fluid flow (8) in thesecond or third fluid flow conduits (55)(57), respectively.

Now referring primarily to FIG. 11A through FIG. 12D, as to particularembodiments, the external ear canal pressure regulation device (1) canbe configured to achieve an external ear canal pressure (10) which canbe lesser or greater than the ambient pressure (11). The effectiveamount of external ear canal pressure (10) to alleviate one or moredisorder symptoms or treat one or more disorders, or the greatest amountof external ear canal pressure (10) achieved in a pressure regulationprofile (73) generated by an embodiment of the external ear canalpressure regulation device (1) can have a range from just above or justbelow the ambient pressure (11) to just above or below the external earcanal pressure (10) at which discomfort may occur to a user (23) orinjury may occur to the auditory meatus (24) or the tympanic membrane(25). While authorities vary on the external ear canal pressure (10)that may result in discomfort to a user (23) or injury to the auditorymeatus (24) or the tympanic membrane (25), typically embodiments of theexternal ear canal pressure regulation device (1) would not beconfigured to operate in excess of about −50 kilopascals below theambient pressure (11) or about +50 kilopascals above the ambientpressure (11).

Now referring primarily to FIG. 2A, FIG. 5, and FIG. 11A through FIG.11D, as to particular embodiments, the external ear canal pressureregulation device (1) can be configured to achieve an external ear canalpressure (10) which can be greater than the ambient pressure (11). Assuch, the valved conduit (5) can be coupled to the fluid flow generator(2) and the axial earpiece bore (4) of the earpiece (3) in the firstconfiguration (45) to unidirectionally regulate the fluid flow (8) inthe first direction (47) in the first fluid flow conduit (5) to egressfrom the axial earpiece bore (4) toward the external ear canal (6).

As shown in FIG. 11A and FIG. 11B, the earpiece external surface (7) ofthe earpiece (3) can be sealably engaged with the external ear canal (6)as described above. Operation of the fluid flow generator (2) cancompress an amount of fluid (74) in the first portion (53) of the firstfluid flow conduit (49). As to those embodiments including avolumetrically adjustable element (13), the resiliently flexible wall(16) can be deformed to reduce the internal volume (19) of thevolumetrically adjustable element (13) to compress the amount of fluid(74) in the first portion (53) of the first fluid flow conduit (49),resulting in a pressure differential (9) between opposite sides of thefirst valve (52) and the second valve (56). As to those embodimentsincluding a piston (27) which reciprocally operates in a barrel (28),the piston (27) can travel within the barrel (28) to reduce the barrelinternal volume, thus resulting in a pressure differential (9) betweenopposite sides of the first valve (52) and the second valve (56).Regardless of the configuration of the fluid flow generator (2), thepressure differential (9) between opposite sides of the first valve (52)can be such that a fluid pressure (75) in the first portion (53) of thefirst fluid flow conduit (49) can be greater than the fluid pressure(75) in the second portion (54) of the first fluid flow conduit (49).This pressure differential (9) can be sufficient to generate the opencondition (69) of the first valve (52). The pressure differential (9)between opposite sides of the second valve (56) can be such that thefluid pressure (75) in the first portion (53) of the first fluid flowconduit (49) can be greater than the ambient pressure (11), which can besufficient to generate the closed condition (68) of the second valve(56). The open condition (69) of the first valve (52) and the closedcondition (68) of the second valve (56) can result in a fluid flow (8)in the first direction (47) in the first fluid flow conduit (49) whichflows from the fluid flow generator (2) through the axial earpiece bore(4) to egress from the earpiece second end (29) into the external earcanal (6), thus increasing the external ear canal pressure (10) togreater than the ambient pressure (11).

As shown in FIG. 11C, continued operation of the fluid flow generator(2) can further act to reduce the pressure differential (9) betweenopposite sides of the first valve (52) and the second valve (56), forexample by allowing the resiliently flexible wall (16) of thevolumetrically adjustable element (13) to return toward the non-deformedcondition (21). The pressure differential (9) between opposite sides ofthe first valve (52) can be such that the fluid pressure (75) in thefirst portion (53) of the first fluid flow conduit (49) can be lesserthan the fluid pressure (75) in the second portion (54) of the firstfluid flow conduit (49). This pressure differential (9) can besufficient to generate the closed condition (68) of the first valve(52), thus interrupting the fluid flow (8) in the first fluid flowconduit (49) from the axial earpiece bore (4) toward the fluid flowgenerator (2) and thereby correspondingly maintaining the pressuredifferential (9) between the external ear canal pressure (10) and theambient pressure (11).

Again referring to FIG. 11C, continued reduction in fluid pressure (75)within the first portion (53) of the first fluid flow conduit (49) canresult in a pressure differential (9) between opposite sides of thesecond valve (56) such that the fluid pressure (75) in the first portion(53) of the first fluid flow conduit (49) can be lesser than the ambientpressure (11), which can be sufficient to generate the open condition(69) of the second valve (56). As such, a fluid flow (8) can begenerated from the ambient pressure (11) through the second fluid flowconduit (55) toward the fluid flow generator (2). As to thoseembodiments having a volumetrically adjustable element (13), the fluidflow (8) from the ambient pressure (11) toward the fluid flow generator(2) can allow the resiliently flexible wall (16) to return toward thenon-deformed condition (21) by increasing the internal volume (19). Asto those embodiments having a piston (27) which reciprocally operates ina barrel (28), the fluid flow (8) through the second fluid flow conduit(55) from the ambient pressure (11) toward the fluid flow generator (2)can allow the piston (27) to return to a location within the barrel (28)which increases the barrel internal volume.

Now referring to FIG. 11D, the third valve (58) in the closed condition(68) can remain substantially leak-tight to fluid flow (8) in the thirdfluid flow conduit (57) up to about a 50 kilopascal pressuredifferential amplitude (59) between the external ear canal pressure (10)and the ambient pressure (11). Accordingly, the external ear canalpressure regulation device (1) can be operated to achieve a desiredexternal ear canal pressure (10) greater than the ambient pressure (11)or to achieve a pre-selected external ear canal pressure (10) greaterthan the ambient pressure (11), beyond which results in the opencondition (69) of the third valve (58), allowing a fluid flow (8) fromthe external ear canal pressure (10) toward ambient pressure (11) tomaintain the desired or pre-selected external ear canal pressure (10).

Now referring primarily to FIG. 5 and FIG. 11D, the third valve (58) canbe operably coupled to a third valve pressure relief element (72)configured to allow manual operation of the third valve (58) between theclosed condition (68) and the open condition (69), facilitating thereturn of the external ear canal pressure (10) toward the ambientpressure (11).

Now referring primarily to FIG. 2B, FIG. 6, and FIG. 12A through FIG.12D, as to particular embodiments, the external ear canal pressureregulation device (1) can be configured to achieve an external ear canalpressure (10) which can be lesser than the ambient pressure (11). Assuch, the valved conduit (5) can be coupled to the fluid flow generator(2) and the axial earpiece bore (4) of the earpiece (3) in the secondconfiguration (46) to unidirectionally regulate the fluid flow (8) inthe second direction (48) in the first fluid flow conduit (49) toingress to the axial earpiece bore (4) from the external ear canal (6)toward the fluid flow generator (2).

As shown in FIG. 12A and FIG. 12B, the earpiece external surface (7) ofthe earpiece (3) can be sealably engaged with the external ear canal (6)as described above. Operation of the fluid flow generator (2) cancompress an amount of fluid (74) in the first portion (53) of the firstfluid flow conduit (49). As to those embodiments including avolumetrically adjustable element (13), the resiliently flexible wall(16) can be deformed to reduce the internal volume (19) of thevolumetrically adjustable element (13) to compress the amount of fluid(74) in the first portion (53) of the first fluid flow conduit (49),resulting in a pressure differential (9) between opposite sides of thefirst valve (52) and the second valve (56). As to those embodimentsincluding a piston (27) which reciprocally operates in a barrel (28),the piston (27) can travel within the barrel (28) to reduce the barrelinternal volume, thus resulting in a pressure differential (9) betweenopposite sides of the first valve (52) and the second valve (56).Regardless of the configuration of the fluid flow generator (2), thepressure differential (9) between opposite sides of the first valve (52)can be such that a fluid pressure (75) in the first portion (53) of thefirst fluid flow conduit (49) can be greater than the fluid pressure(75) in the second portion (54) of the first fluid flow conduit (49).This pressure differential (9) can be sufficient to generate the closedcondition (68) of the first valve (52). The pressure differential (9)between opposite sides of the second valve (56) can be such that thefluid pressure (75) in the first portion (53) of the first fluid flowconduit (49) can be greater than the ambient pressure (11), which can besufficient to generate the open condition (69) of the second valve (56),which can generate a fluid flow (8) in the second fluid flow conduit(55) from the fluid flow generator (2) toward the ambient pressure (11).

As shown in FIG. 12C, continued operation of the fluid flow generator(2) can further act to reduce the pressure differential (9) betweenopposite sides of the first valve (52) and the second valve (56), forexample by allowing the resiliently flexible wall (16) of thevolumetrically adjustable element (13) to return toward the non-deformedcondition (21). The pressure differential (9) between opposite sides ofthe first valve (52) can be such that the fluid pressure (75) in thefirst portion (53) of the first fluid flow conduit (49) can be lesserthan the fluid pressure (75) in the second portion (54) of the firstfluid flow conduit (49). This pressure differential (9) can besufficient to generate the open condition (69) of the first valve (52),which can result in a fluid flow (8) from the external ear canal (6)toward the fluid flow generator (2), thus decreasing the external earcanal pressure (10) to lesser than the ambient pressure (11).

Again referring to FIG. 12C, continued reduction in fluid pressure (75)within the first portion (53) of the first fluid flow conduit (49) canresult in a pressure differential (9) between opposite sides of thesecond valve (56) such that the fluid pressure (75) in the first portion(53) of the first fluid flow conduit (49) can be lesser than the ambientpressure (11), which can be sufficient to generate the closed condition(68) of the second valve (56), thus interrupting the fluid flow (8) inthe second fluid flow conduit (55) from the fluid flow generator (2)toward the ambient pressure (11) and correspondingly maintaining thepressure differential (9) between the external ear canal pressure (10)and the ambient pressure (11).

As to those embodiments having a volumetrically adjustable element (13),the fluid flow (8) from the external ear canal (6) toward the fluid flowgenerator (2) can allow the resiliently flexible wall (16) to returntoward the non-deformed condition (21) by increasing the internal volume(19). As to those embodiments having a piston (27) which reciprocallyoperates in a barrel (28), the fluid flow (8) through the first fluidflow conduit (49) from the external ear canal (6) toward the fluid flowgenerator (2) can allow the piston (27) to return to a location withinthe barrel (28) which increases the barrel internal volume.

Now referring to FIG. 12D, the third valve (58) in the closed condition(68) can remain substantially leak-tight to fluid flow (8) in the thirdfluid flow conduit (57) up to about a 50 kilopascal pressuredifferential amplitude (59) between the external ear canal pressure (10)and the ambient pressure (11). Accordingly, the external ear canalpressure regulation device (1) can be operated to achieve a desiredexternal ear canal pressure (10) lesser than the ambient pressure (11)or to achieve a pre-selected external ear canal pressure (10) lesserthan ambient pressure (11), beyond which results in the open condition(69) of the third valve (58), allowing a fluid flow (8) from the ambientpressure (11) toward the external ear canal (6) to maintain the desiredor pre-selected external ear canal pressure (10).

Now referring primarily to FIG. 6 and FIG. 12D, the third valve (58) canbe operably coupled to a third valve pressure relief element (72)configured to allow manual operation of the third valve (58) between theclosed condition (68) and the open condition (69), facilitating thereturn of the external ear canal pressure (10) toward the ambientpressure (11).

Now referring primarily to FIG. 13A through FIG. 13F, a particularembodiment of the external ear canal pressure regulation device (1) caninclude a fluid flow generator (2) configured as a diaphragm (15), whichhas a resiliently flexible wall (16) having a wall external surface (17)and a wall internal surface (18), which defines an internal volume (19)(whether in whole or in part as an assembly with the valved conduit(5)). The resiliently flexible wall (16) in a deformed condition (20)can decrease the internal volume (19), and in return toward anon-deformed condition (21), can increase the internal volume (19). Thechange in the internal volume (19) can generate a fluid flow (8) betweenthe fluid flow generator (2) and an axial earpiece bore (4) of anearpiece (3), which can be regulated by a valved conduit (5).

Again referring primarily to FIG. 13A through FIG. 13F, the external earcanal pressure regulation device (1) can include a valved conduit (5)fluidicly coupled between the fluid flow generator (2) and the axialearpiece bore (4). As to particular embodiments, the earpiece (3) havingthe axial earpiece bore (4) and first, second, and third fluid flowconduits (49)(55)(57) can be included in a conduit body (41) having aconfiguration which removably couples to the fluid flow generator (2)and the first, second, and third valves (52)(56)(58). As to particularembodiments, the first and second valves (52)(56) can be included in afirst valve assembly (83), which can be fluidicly coupled between thefluid flow generator (2) and the first and second fluid flow conduits(49)(55) to interrupt the fluid flow (8) between the fluid flowgenerator (2) and the first and second fluid flow conduits (49)(55),thereby unidirectionally regulating the fluid flow (8) in the first andsecond fluid flow conduits (49)(55).

The third valve (58) can be included in a second valve assembly (84),which can be fluidicly coupled to a third fluid flow conduit (57)communicating between the first fluid flow conduit (49) and the ambientpressure (11) to interrupt the fluid flow (8) between the third fluidflow conduit (57) and the ambient pressure (11), therebyunidirectionally regulating the fluid flow (8) in the third fluid flowconduit (57) between the first fluid flow conduit (49) and the ambientpressure (11). As to particular embodiments, the fluid flow generator(2) and the first and second valve assemblies (83)(84) can be providedas a one-piece construct. As to other particular embodiments, the fluidflow generator (2), the first valve assembly (83), and the second valveassembly (84) can be provided as a plurality of pieces which can beassembled into a configuration capable of removably coupling to theconduit body (41).

As to particular embodiments, the first and second valves (52)(56)included in the first valve assembly (83) can have any type of valveconfiguration, as described above, which can operate between a closedcondition (68) and an open condition (69) to unidirectionally regulatefluid flow (8) in a pre-selected range. As an illustrative example, thefirst and second valves (52)(56) included in the first valve assembly(83) can both be configured as flapper valves (64) having hinges (94)(as shown in the example of FIG. 3B, and FIG. 13C though FIG. 13F)having opposing configurations.

As to particular embodiments, the second valve assembly (84) can beoperable to allow the external ear canal pressure (10) to return towardthe ambient pressure (11). The second valve assembly (84) can include aresiliently deformable annular member (85) and a pressure relief element(70) configured as a deformation member (86) capable of deforming theresiliently deformable annular member (85). The resiliently deformableannular member (85) can have an annular member external surface (87)which can be disposed adjacent to and sealably engage with the conduitinternal surface (88) of the first fluid flow conduit (49).

An annular member aperture element (89) communicating between an annularmember internal surface (90) and the annular member external surface(87) can align with the axial earpiece bore (4) to form a pass-through(91) between the first fluid flow conduit (49) and the axial earpiecebore (4). The deformation member (86) can be disposed through the thirdfluid flow conduit (57) communicating between the first fluid flowconduit (49) and the ambient pressure (11) such that a deformationmember first end (92) can extend outward from the third fluid flowconduit (57) and the conduit body (41) and a deformation member secondend (93) can deformably engage the annular member external surface (87).Upon gripping engagement of the deformation member first end (92), thedeformation member (86) can be urged toward the resiliently deformableannular member (85) to deform the resiliently deformable annular member(85) such that the annular member external surface (87) disengages fromthe conduit internal surface (88) of the first fluid flow conduit (49),thereby positioning the third valve (58) in the open condition (69) toallow the fluid flow (8) to flow between the axial earpiece bore (4),the first and third fluid flow conduits (49)(57), and the ambientpressure (11). As such, the third valve (58) in the open condition (69)can generate a fluid flow (8) between the external ear canal (6) and theambient pressure (11) to return the external ear canal pressure (10)toward the ambient pressure (11), whether from an external ear canalpressure (10) greater than the ambient pressure (11) or an external earcanal pressure (10) lesser than the ambient pressure (11).

The fluid flow generator (2), the first valve assembly (83), and thesecond valve assembly (84) can be removably coupled to the conduit body(41) in either one of a first configuration (45) or a secondconfiguration (46). The releasably couplable surfaces (44) of theconduit body (41), the fluid flow generator (2), the first valveassembly (83), and the second valve assembly (84) can have sufficientlysimilar configurations to allow the conduit body (41) to removablycouple to the fluid flow generator (2), the first valve assembly (83),and the second valve assembly (84) in either one of the firstconfiguration (45) or the second configuration (46) depending uponwhether the valved conduit (5) operates to achieve a pressuredifferential (9) having the external ear canal pressure (10) greaterthan the ambient pressure (11) (as shown in the example of FIG. 13E) orwhether the valved conduit (5) operates to achieve a pressuredifferential (9) having the external ear canal pressure (10) lesser thanambient the pressure (11) (as shown in the example of FIG. 13F). As toparticular embodiments, to removably couple, the releasably couplablesurfaces (44) of the conduit body (41), the fluid flow generator (2),the first valve assembly (83), and the second valve assembly (84) canmatably engage.

As to the particular embodiments of the external ear canal pressureregulation device (1) described herein, the first and second valves(52)(56) fluidicly couple to the corresponding first and second fluidflow conduits (49)(55) to interrupt the fluid flow (8) within thecorresponding first and second fluid flow conduits (49)(55), whether theconduit body (41) can be positioned in the first configuration (45) orthe second configuration (46).

Now referring primarily to FIG. 13E, as an illustrative example, thefluid flow generator (2), the first valve assembly (83), and the conduitbody (41) can be positioned in the first configuration (45) by removablycoupling the fluid flow generator (2) and the first valve assembly (83)to the conduit body (41). In the first configuration (45), the firstvalve (52) can be operable to unidirectionally regulate the fluid flow(8) in the first fluid flow conduit (49), whereby the first valve (52)in the open condition (69) allows the fluid flow (8) to flow from thefluid flow generator (2) toward the axial earpiece bore (4) and, in theclosed condition (68), precludes the fluid flow (8) from flowing betweenthe fluid flow generator (2) and the axial earpiece bore (4). As such,the fluid flow (8), generated by deforming the resiliently flexible wall(16) of the diaphragm (15) to decrease the internal volume (19), can beregulated in a first direction (47) in the first fluid flow conduit (49)to egress from the axial earpiece bore (4) toward the external ear canal(6), thereby achieving a pressure differential (9) having the externalear canal pressure (10) greater than the ambient pressure (11). Uponachieving the desired pressure differential (9) between the external earcanal pressure (10) and the ambient pressure (11), the resilientlyflexible wall (16) of the diaphragm (15) can be allowed to return to thenon-deformed condition (21), thereby closing the first valve (52) andprecluding the fluid flow (8) from flowing from the axial earpiece bore(4) toward the fluid flow generator (2), thereby maintaining the desiredpressure differential (9).

In the first configuration (45), the second valve (56) can be operableto unidirectionally regulate the fluid flow (8) in the second fluid flowconduit (55), whereby the second valve (56) in the open condition (69)allows the fluid flow (8) to flow from the ambient pressure (11) towardthe fluid flow generator (2) and, in the closed condition (68),precludes the fluid flow (8) from flowing between the ambient pressure(11) and the fluid flow generator (2).

As such, the fluid flow (8), generated upon return of the resilientlyflexible wall (16) of the diaphragm (15) to the non-deformed condition(21) to increase the internal volume (19), can be regulated in thesecond fluid flow conduit (55) to ingress from the ambient pressure (11)toward the fluid flow generator (2), thereby maintaining the desiredpressure differential (9) between the external ear canal pressure (10)and the ambient pressure (11) while allowing the resiliently flexiblewall (16) of the diaphragm (15) to return toward the non-deformedcondition (21).

As to particular embodiments, the fluid flow generator (2), the firstvalve assembly (83), and the conduit body (41) in the firstconfiguration (45) can further include the second valve assembly (84),positioned such that the third valve (58) can be fluidicly coupled tothe third fluid flow conduit (57) communicating between the first fluidflow conduit (49) and the ambient pressure (11) to unidirectionallyregulate the fluid flow (8) in the third fluid flow conduit (57) betweenthe first fluid flow conduit (49) and the ambient pressure (11). Thethird valve (58) in the open condition (69) allows the fluid flow (8) toflow from the axial earpiece bore (4), through the first and third fluidflow conduits (49)(57), and toward the ambient pressure (11) and, in theclosed condition (68), precludes the fluid flow (8) from flowing betweenthe axial earpiece bore (4) and the ambient pressure (11). As such, thethird valve (58) in the open condition (69) can generate a fluid flow(8) from the external ear canal (6) toward the ambient pressure (11) toreturn the external ear canal pressure (10) toward the ambient pressure(11).

As to particular embodiments, the fluid flow generator (2), the firstvalve assembly (83), and the second valve assembly (84) can be removedfrom the conduit body (41) to disassemble the first configuration (45).The first valve assembly (83) can be rotated without any structuralalteration to reverse orientation of the first valve assembly (83) inrelation to the conduit body (41), thereby achieving the secondconfiguration (46).

Now referring primarily to FIG. 13F, as an illustrative example, thefluid flow generator (2), the first valve assembly (83), and the conduitbody (41) can be positioned in the second configuration (46) asdescribed above. In the second configuration (46), the second valve (56)can be operable to unidirectionally regulate the fluid flow (8) in thesecond fluid flow conduit (55), whereby the second valve (56) in theopen condition (69) allows the fluid flow (8) to flow from the fluidflow generator (2) toward the ambient pressure (11) and, in the closedcondition (68), precludes the fluid flow (8) from flowing between thefluid flow generator (4) and the ambient pressure (11). As such, thefluid flow (8), generated by deforming the resiliently flexible wall(16) of the diaphragm (15) to decrease the internal volume (19), can beregulated in the second fluid flow conduit (55) to egress from thesecond fluid flow conduit (55) toward the ambient pressure (11). Theresiliently flexible wall (16) of the diaphragm (15) can be allowed toreturn to the non-deformed condition (21), thereby closing the secondvalve (56) and precluding the fluid flow (8) from flowing between thefluid flow generator (2) and the ambient pressure (11).

In the second configuration (46), the first valve (52) can be operableto unidirectionally regulate the fluid flow (8) in the first fluid flowconduit (49), whereby the first valve (52) in the open condition (69)allows the fluid flow (8) to flow from the axial earpiece bore (4)toward the fluid flow generator (2) and, in the closed condition (68),precludes the fluid flow (8) from flowing between the axial earpiecebore (4) and the fluid flow generator (2).

As such, the fluid flow (8), generated upon return of the resilientlyflexible wall (16) of the diaphragm (15) to the non-deformed condition(21) to increase the internal volume (19), can be regulated in a seconddirection (48) in the first fluid flow conduit (56) to ingress from theexternal ear canal (6) to the axial earpiece bore (4) toward the fluidflow generator (2), thereby achieving a pressure differential (9) havingthe external ear canal pressure (10) lesser than the ambient pressure(11). Upon achieving the desired pressure differential (9) between theexternal ear canal pressure (10) and the ambient pressure (11), thefirst valve (52) can return toward the closed condition (68), precludingthe fluid flow (8) from flowing between the axial earpiece bore (4) andthe fluid flow generator (2), thereby maintaining the desired pressuredifferential (9) between the external ear canal pressure (10) and theambient pressure (11).

As to particular embodiments, the fluid flow generator (2), the firstvalve assembly (83), and the conduit body (41) in the secondconfiguration (46) can further include the second valve assembly (84),positioned such that the third valve (58) can be fluidicly coupled tothe third fluid flow conduit (57) communicating between the first fluidflow conduit (49) and the ambient pressure (11) to unidirectionallyregulate the fluid flow (8) in the third fluid flow conduit (57) betweenthe first fluid flow conduit (49) and the ambient pressure (11). Thethird valve (58) in the open condition (69) allows the fluid flow (8) toflow from the ambient pressure (11), through the third and first fluidflow conduits (57)(49), and toward the axial earpiece bore (4) and, inthe closed condition (68), precludes the fluid flow (8) from flowingbetween the ambient pressure (11) and the axial earpiece bore (4). Assuch, the third valve (58) in the open condition (69) can generate afluid flow (8) from the ambient pressure (11) toward the external earcanal (6) to return the external ear canal pressure (10) toward theambient pressure (11).

Now referring primarily to FIG. 14A through FIG. 15G, which show apressure differential (9) between the external ear canal pressure (10)and the ambient pressure (11) achieved over a time period (76) byoperation of embodiments of the external ear canal pressure regulationdevice (1). As to particular embodiments, a fluid flow generator (2)comprising a volumetrically adjustable element (13) can be operated froma non-deformed condition (21) toward a deformed condition (20) togenerate a fluid flow (8) in a first direction (47) which egresses fromthe axial earpiece bore (4) toward the external ear canal (6) over atime period (76), resulting in a positive external ear canal pressure(10) relative to the ambient pressure (11) (as shown in the examples ofFIG. 14A through FIG. 14G). As to other particular embodiments, a fluidflow generator (2) comprising a volumetrically adjustable element (13)can be operated from a deformed condition (20) toward a non-deformedcondition (21) to generate a fluid flow (8) in a second direction (48)which ingresses to the axial earpiece bore (4) from the external earcanal (6) toward the fluid flow generator (2) over a time period (76),resulting in a negative external ear canal pressure (10) relative to theambient pressure (11) (as shown in the examples of FIG. 15A through FIG.15G).

Now referring primarily to FIG. 14A and FIG. 15A, the fluid flowgenerator (2) can be operated to maintain a constant pressure amplitude(77) over a time period (76). As to particular embodiments, a constantpressure amplitude (77) can be maintained substantially without fluidflow (8) of a fluid volume (12) within the external ear canal (6) overthe time period (76). As an illustrative example, the external ear canalpressure regulation device (1) having the earpiece external surface (7)sealably engaged with the external ear canal (6), as described above,can be operated by manipulating the fluid flow generator (2) to generatea fluid flow (8) of a fluid volume (12) between the fluid flow generator(2) and the external ear canal (6) through the axial earpiece bore (4)of the earpiece (3) to achieve a pressure differential (9) between theexternal ear canal pressure (10) and the ambient pressure (11). Once thedesired pressure differential (9) between the external ear canalpressure (10) and the ambient pressure (11) has been achieved, thepressure amplitude (77) can be maintained for a time period (76) withoutadditional fluid flow (8) of the fluid volume (12), for example byoperation of the first valve (52) configured to allow unidirectionalfluid flow (8) of the fluid volume (12) through the first fluid flowconduit (49) such that the fluid volume (12) can only either ingress oregress from the external ear canal (6). As to other embodiments, oncethe desired pressure differential (9) between the external ear canalpressure (10) and the ambient pressure (11) has been achieved, thepressure amplitude (77) can be maintained for a time period (76) byadditional fluid flow (8) of a fluid volume (12) to or from the externalear canal (6) to offset leakage about engagement of the earpieceexternal surface (7) with the external ear canal (6). As to otherembodiments, the pressure amplitude (77) can be maintained for a timeperiod (76) by continuous fluid flow (8) of a fluid volume (12) in theexternal ear canal (6).

The constant pressure amplitude (77) can be maintained over a timeperiod (76) to alleviate a disorder symptom or treat a disorder, wherebythe constant pressure amplitude (77) can be in a range of between about+50 kilopascals above the ambient pressure (11) to about −50 kilopascalsbelow the ambient pressure (11). A positive external ear canal pressure(10) relative to the ambient pressure (11) can be achieved bymaintaining the constant pressure amplitude (77) in a range of betweenabout 0 kilopascals to about +50 kilopascals above the ambient pressure(11). Alternatively, a negative external ear canal pressure (10)relative to the ambient pressure (11) can be achieved by maintaining theconstant pressure amplitude (77) in a range of between about −50kilopascals to about 0 kilopascals below the ambient pressure (11).

Now referring primarily to FIG. 14B through FIG. 14G and FIG. 15Bthrough FIG. 15G, the fluid flow generator (2) can be configured forrepeated operation to generate a fluid flow (8) having a pressure wave(78) including a pressure wave amplitude (77) and a pressure wavefrequency (79). As to particular embodiments, a fluid flow generator (2)comprising a volumetrically adjustable element (13) can be operated froma non-deformed condition (21) toward a deformed condition (20) togenerate a fluid flow (8) which egresses from the axial earpiece bore(4) toward the external ear canal (6) over a time period (76), wherebythe fluid flow (8) has a pressure wave (78) including a pressure waveamplitude (77) and a pressure wave frequency (79) which results in apositive external ear canal pressure (10) relative to the ambientpressure (11) (as shown in the examples of FIG. 14B through FIG. 14G).As to other particular embodiments, a fluid flow generator (2)comprising a volumetrically adjustable element (13) can be operated froma deformed condition (20) toward a non-deformed condition (21) togenerate a fluid flow (8) which ingresses to the axial earpiece bore (4)from the external ear canal (6) toward the fluid flow generator (2) overa time period (76), whereby the fluid flow (8) has a pressure wave (78)including a pressure wave amplitude (77) and a pressure wave frequency(79) which results in a negative external ear canal pressure (10)relative to the ambient pressure (11) (as shown in the examples of FIG.15B through FIG. 15G).

Again referring primarily to FIG. 14A through FIG. 15G, the fluid flowgenerator (2) can be configured for repeated operation to generate afluid flow (8) having a pressure wave (78) including a pressure waveamplitude (77) as described above and a pressure wave frequency (79)typically in a range of between 0 Hertz to about 10 Hertz; however,embodiments can have a lesser or greater pressure wave frequency (79)depending upon the application. As to particular embodiments, one ormore pressure wave frequencies (79) can be selected from the groupincluding or consisting of: between 0 Hertz to about 1 Hertz, betweenabout 0.5 Hertz to about 1.5 Hertz, between about 1 Hertz to about 2Hertz, between about 1.5 Hertz to about 2.5 Hertz, between about 2 Hertzto about 3 Hertz, between about 2.5 Hertz to about 3.5 Hertz, betweenabout 3 Hertz to about 4 Hertz, between about 3.5 Hertz to about 4.5Hertz, between about 4 Hertz to about 5 Hertz, between about 4.5 Hertzto about 5.5 Hertz, between about 5 Hertz to about 6 Hertz, betweenabout 5.5 Hertz to about 6.5 Hertz, between about 6 Hertz to about 7Hertz, between about 6.5 Hertz to about 7.5 Hertz, between about 7 Hertzto about 8 Hertz, between about 7.5 Hertz to about 8.5 Hertz, betweenabout 8 Hertz to about 9 Hertz, between about 8.5 Hertz to about 9.5Hertz, and between about 9 Hertz to about 10 Hertz.

One or more pressure wave frequencies (79) can be generated with theexternal ear canal pressure regulation device (1) depending upon themethod of use, which can be further influenced by factors such as user(23) anatomy, physiology, or biochemistry of the auditory meatus (24);disorder symptom targeted for alleviation; disorder targeted fortreatment; observable effect(s) of using one or more pressure wavefrequencies (79) in a particular method of using the external ear canalpressure regulation device (1); or the like; or combinations thereof;but not so much as to cause discomfort to the user (23) or injury to theauditory meatus (24) or the tympanic membrane (25).

The pressure wave (78) can oscillate with a desired pressure wavefrequency (79) within only positive pressure amplitudes (77) in a rangeof between 0 kilopascals to about +50 kilopascals above the ambientpressure (11) (as shown in the examples of FIG. 14B through FIG. 14G),which can correspondingly generate a positive external ear canalpressure (10) relative to the ambient pressure (11) by increasing theexternal ear canal pressure (10) relative to the ambient pressure (11),for example to alleviate a disorder symptom or treat a disorder. As toyet other particular embodiments, the pressure wave (78) can oscillatewith a desired pressure wave frequency (79) within only negativepressure amplitudes (77) in a range of between about −50 kilopascals to0 kilopascals below the ambient pressure (11) (as shown in the examplesof FIG. 15B through FIG. 15G), which can correspondingly generate anegative external ear canal pressure (10) relative to the ambientpressure (11) by decreasing the external ear canal pressure (10)relative to the ambient pressure (11), for example to alleviate adisorder symptom or treat a disorder.

Again referring primarily to FIG. 14B through FIG. 15G, the pressurewave (78) can have a numerous and wide variety of waveforms, dependingupon the application, corresponding to the numerous and wide variety ofsymptoms which can be alleviated or disorders which can be treated byoperation of the external ear canal pressure regulation device (1). Asillustrative examples, the pressure wave (78) can be sine wave havingsmooth repetitive periodic oscillations (as shown in the example of FIG.14B and FIG. 15B), a square wave in which the pressure amplitude (77)alternates at a steady frequency between fixed minimum and maximumvalues, a rectangular wave, a trapezoidal wave or a truncated wave inwhich the apex of the pressure wave (78) has a constant pressureamplitude (77) over a time period (76) (as shown in the example of FIG.14C, FIG. 15C, FIG. 14F, and FIG. 15F), a triangle wave having linearleading and trailing edges (as shown in the example of FIG. 14D and FIG.15D), a sawtooth wave in which the leading edge changes pressureamplitude (77) over a time period (76) which is greater than the timeperiod (76) in which the trailing edge changes pressure amplitude (77)(as shown in the example of FIG. 14E), a reverse sawtooth wave in whichthe leading edge changes pressure amplitude (77) over a time period (76)which is lesser than the time period (76) in which the trailing edgechanges pressure amplitude (77) (as shown in the example of FIG. 15E),or combinations thereof (as shown in the example of FIG. 14G and FIG.15G).

As to particular embodiments, the fluid flow generator (2) and the thirdvalve pressure relief element (72) coupled to the third valve (58) canbe alternately repeatedly operated to generate a fluid flow (8) having apressure wave (78) including a pressure wave amplitude (77) and apressure wave frequency (79).

Now referring primarily to FIG. 14A through FIG. 14G, which show apressure differential (9) between the external ear canal pressure (10)and the ambient pressure (11) achieved over a time period (76) byoperation of embodiments of the external ear canal pressure regulationdevice (1) to generate a positive external ear canal pressure (10)relative to the ambient pressure (11) (as shown in the examples of FIG.2A, FIG. 5, and FIG. 11A through FIG. 11D). The particular embodiment ofthe external ear canal pressure regulation device (1) includes a thirdvalve (58) which remains substantially leak-tight to fluid flow (8) inthe third fluid flow conduit (57) up to about a 50 kilopascal pressuredifferential amplitude (59) between the external ear canal pressure (10)and the ambient pressure (11) (represented in each graph as having apressure amplitude (77) of zero). However, this need not limitembodiments solely to those capable of generating a positive externalear canal pressure (10) relative to the ambient pressure (11)pre-selected to a maximum of +50 kilopascals. Other embodiments canoperate to generate a positive external ear canal pressure (10) relativeto the ambient pressure (11) which can be any amount greater than theambient pressure (11), but not an amount so great as to cause discomfortto the user (23) or injury to the auditory meatus (24) or the tympanicmembrane (25).

Now referring primarily to FIG. 14A, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout +50 kilopascals above the ambient pressure (11). The external earcanal pressure (10) can be maintained for a time period (76) at about+50 kilopascals above the ambient pressure (11). After elapse of thetime period (76), the third valve pressure relief element (72) can beoperated to return the external ear canal pressure (10) toward theambient pressure (11). The operation can be, but is not necessarily,repeated.

Now referring primarily to FIG. 14B, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout +50 kilopascals above the ambient pressure (11). The third valvepressure relief element (72) can be operated to return the external earcanal pressure (10) toward the ambient pressure (11), whereby thepressure wave (78) can be a sine wave having smooth repetitive periodicoscillations. The operation can be repeated to administer a pulsatilechange in the external ear canal pressure (10).

Now referring primarily to FIG. 14D, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout +50 kilopascals above the ambient pressure (11). The third valvepressure relief element (72) can be operated to return the external earcanal pressure (10) toward the ambient pressure (11), whereby thepressure wave (78) can be a triangle wave having linear leading andtrailing edges. The operation can be repeated to administer a pulsatilechange in the external ear canal pressure (10).

Now referring primarily to FIG. 14E, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout +50 kilopascals above the ambient pressure (11). The third valvepressure relief element (72) can be operated to return the external earcanal pressure (10) toward the ambient pressure (11), whereby thepressure wave (78) can be a sawtooth wave in which the leading edgechanges pressure amplitude (77) over a time period (76) which is greaterthan the time period (76) in which the trailing edge changes pressureamplitude (77). The operation can be repeated to administer a pulsatilechange in the external ear canal pressure (10).

Now referring primarily to FIG. 14C and FIG. 14F, as to a particularembodiment, the fluid flow generator (2) can be operated to generate anexternal ear canal pressure (10) having a maximum pressure amplitude(77) of up to about +50 kilopascals above the ambient pressure (11). Theexternal ear canal pressure (10) can be maintained for a time period(76) at about +50 kilopascals above the ambient pressure (11). Afterelapse of the time period (76), the third valve pressure relief element(72) can be operated to return the external ear canal pressure (10)toward the ambient pressure (11). The operation can be repeated toadminister a pulsatile change in the external ear canal pressure (10).

Now referring primarily to FIG. 14G, as to a particular embodiment, thefluid flow generator (2) can be operated to increase the external earcanal pressure (10) in a series of incremental pressure increases havinga maximum pressure amplitude (77) of about +50 kilopascals above theambient pressure (11). Each of the series of incremental pressureincreases can increase the external ear canal pressure (10) by about 10kilopascals to about 15 kilopascals above the ambient pressure (11),with each incremental pressure increase in the external ear canalpressure (10) maintained for a time period (76). After achieving themaximum pressure amplitude (77) of about +50 kilopascals above theambient pressure (11) and elapse of the time period (76), the thirdvalve pressure relief element (72) can be operated to return theexternal ear canal pressure (10) toward the ambient pressure (11). Theoperation can be repeated to administer a pulsatile change in theexternal ear canal pressure (10).

Now referring primarily to FIG. 15A through FIG. 15G, which show apressure differential (9) between the external ear canal pressure (10)and the ambient pressure (11) achieved over a time period (76) byoperation of embodiments of the external ear canal pressure regulationdevice (1) to generate a negative external ear canal pressure (10)relative to the ambient pressure (9) (as shown in the examples of FIG.2B, FIG. 6, and FIG. 12A through FIG. 12D). The particular embodiment ofthe external ear canal pressure regulation device (1) includes a thirdvalve (58) which remains substantially leak-tight to fluid flow (8) inthe third fluid flow conduit (57) up to about a 50 kilopascal pressuredifferential amplitude (59) between the external ear canal pressure (10)and the ambient pressure (11) (represented in each graph as having apressure amplitude (77) of zero). However, this need not limitembodiments solely to those capable of generating a negative externalear canal pressure (10) relative to the ambient pressure (77)pre-selected to a maximum of −50 kilopascals. Other embodiments canoperate to generate a negative external ear canal pressure (10) relativeto the ambient pressure (11) which can be any amount lesser than theambient pressure (11), but not an amount so great as to cause discomfortto the user (23) or injury to the auditory meatus (24) or the tympanicmembrane (25).

Now referring primarily to FIG. 15A, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout −50 kilopascals below the ambient pressure (11). The external earcanal pressure (10) can be maintained for a time period (76) at about−50 kilopascals below the ambient pressure (11). After elapse of thetime period (76), the third valve pressure relief element (72) can beoperated to return the external ear canal pressure (10) toward theambient pressure (11). The operation can be, but is not necessarily,repeated.

Now referring primarily to FIG. 15B, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout −50 kilopascals below the ambient pressure (11). The third valvepressure relief element (72) can be operated to return the external earcanal pressure (10) toward the ambient pressure (11), whereby thepressure wave (78) can be a sine wave having smooth repetitive periodicoscillations. The operation can be repeated to administer a pulsatilechange in the external ear canal pressure (10).

Now referring primarily to FIG. 15D, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout −50 kilopascals below the ambient pressure (11). The third valvepressure relief element (72) can be operated to return the external earcanal pressure (10) toward the ambient pressure (11), whereby thepressure wave (78) can be a triangle wave having linear leading andtrailing edges. The operation can be repeated to administer a pulsatilechange in the external ear canal pressure (10).

Now referring primarily to FIG. 15E, as to a particular embodiment, thefluid flow generator (2) can be operated to generate an external earcanal pressure (10) having a maximum pressure amplitude (77) of up toabout −50 kilopascals below the ambient pressure (11). The third valvepressure relief element (72) can be operated to return the external earcanal pressure (10) toward the ambient pressure (11), whereby thepressure wave (78) can be a reverse sawtooth wave in which the leadingedge changes pressure amplitude (77) over a time period (76) which islesser than the time period (76) in which the trailing edge changespressure amplitude (77). The operation can be repeated to administer apulsatile change in the external ear canal pressure (10).

Now referring primarily to FIG. 15C and FIG. 15F, as to a particularembodiment, the fluid flow generator (2) can be operated to generate anexternal ear canal pressure (10) having a maximum pressure amplitude(77) of up to about −50 kilopascals below the ambient pressure (11). Theexternal ear canal pressure (10) can be maintained for a time period(76) at about −50 kilopascals below the ambient pressure (11). Afterelapse of the time period (76), the third valve pressure relief element(72) can be operated to return the external ear canal pressure (10)toward the ambient pressure (11). The operation can be repeated toadminister a pulsatile change in the external ear canal pressure (10).

Now referring primarily to FIG. 15G, as to a particular embodiment, thefluid flow generator (2) can be operated to decrease the external earcanal pressure (10) in a series of incremental pressure decreases havinga maximum pressure amplitude (77) of about −50 kilopascals below theambient pressure (11). Each of the series of incremental pressuredecreases can decrease the external ear canal pressure (10) by about −10kilopascals to about −15 kilopascals below the ambient pressure (11),with each incremental pressure decrease in the external ear canalpressure (10) maintained for a time period (76). After achieving themaximum pressure amplitude (77) of about −50 kilopascals below theambient pressure (11) and elapse of the time period (76), the thirdvalve pressure relief element (72) can be operated to return theexternal ear canal pressure (10) toward the ambient pressure (11). Theoperation can be repeated to administer a pulsatile change in theexternal ear canal pressure (10).

As to particular embodiments, the external ear canal pressure regulationdevice (1) can further include a housing (80) having a housing internalsurface defining a generally hollow internal space in which componentsof the external ear canal pressure regulation device (1) can be housed.As to particular embodiments, the housing (80) can be configured to filla concha area (82) of the ear (35), whether in whole or in part, withoutextending any substantial distance outside of the external auditorymeatus (24), thereby providing a discrete, unobtrusive, portableconfiguration which can be used upon occurrence to alleviate one or moredisorder symptoms, for example neurologically-mediated pain, or treatone or more disorders, for example craniofacial pain syndromes orheadache syndromes.

While the fluid flow generator (2) of the external ear canal pressureregulation device (1) above described typically delivers a fluid flow(8) of air to the external ear canal (6) to achieve the pressuredifferential (9) between the external ear canal pressure (10) and theambient pressure (11), this is not intended to be limiting with respectto the wide variety of fluids which can be delivered to the external earcanal (6) by the external ear canal pressure regulation device (1). Asillustrative examples, the wide variety of fluids can include: apurified gas, such as oxygen, nitrogen, argon, or the like; a mixture ofpartial pressures of gases; a liquid, such as water, oil, alcohol, orthe like; or combinations thereof.

Additionally, while the fluid flow (8) or the transfer of a fluid volume(12) between components of the external ear canal pressure regulationdevice (1), between components of the external ear canal pressureregulation device (1) and the external ear canal (6), or betweencomponents of the external ear canal pressure regulation device (1) andthe ambient pressure (11) can be above described as typically between afirst point and a second point for the purpose of brevity, the fluidflow (8) or the transfer of the fluid volume (12) includes all pointswithin the manifold fluid flow path (62) between the first point and thesecond point. For example, a fluid volume (12) transferred from thefluid flow generator (2) to the external ear canal (6) can travel alonga fluid flow path (62) including the fluid flow generator (2), the firstfluid flow conduit first end (50), the first portion (53) of the firstfluid flow conduit (49), the first valve (52), the second portion (54)of the first fluid flow conduit (49), the first fluid flow conduitsecond end (51), the earpiece first end (31), the axial earpiece bore(4), the earpiece second end (29), and the external ear canal (6).

A method of producing particular embodiments of the external ear canalpressure regulation device (1) can include providing a fluid flowgenerator (2) capable of generating a fluid flow (8); providing a valvedconduit (5) capable of fluidicly coupling to the fluid flow generator(2), the valved conduit (5) having a first fluid flow conduit (49);providing a first valve (52) capable of interrupting the first fluidflow conduit (49) to unidirectionally regulate the fluid flow (8) in thefirst fluid flow conduit (49); and providing an axial earpiece bore (4),which communicates between an earpiece first end (31) and an earpiecesecond end (32) of an earpiece (3), the axial earpiece bore (4) capableof fluidicly coupling to the valved conduit (5) opposite the fluid flowgenerator (2), the earpiece (3) having a compliant earpiece externalsurface (7) configured to sealably engage an external ear canal (6) as abarrier between an external ear canal pressure (10) and an ambientpressure (11).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing a fluidflow generator (2) having a configuration capable of generating thefluid flow (8) having a fluid volume (12) in a range of between 0milliliters to about 20 milliliters. As to particular embodiments, thefluid volume (12) can have a pre-selected fluid volume (12), which canbe selected from one or more of the group including or consisting of:between 0 milliliters to about 2 milliliters, between about 1 milliliterto about 3 milliliters, between about 2 milliliters to about 4milliliters, between about 3 milliliters to about 5 milliliters, betweenabout 4 milliliters to about 6 milliliters, between about 5 millilitersto about 7 milliliters, between about 6 milliliters to about 8milliliters, between about 7 milliliters to about 9 milliliters, betweenabout 8 milliliters to about 10 milliliters, between about 9 millilitersto about 11 milliliters, between about 10 milliliters to about 12milliliters, between about 11 milliliters to about 13 milliliters,between about 12 milliliters to about 14 milliliters, between about 13milliliters to about 15 milliliters, between about 14 milliliters toabout 16 milliliters, between about 15 milliliters to about 17milliliters, between about 16 milliliters to about 18 milliliters,between about 17 milliliters to about 19 milliliters, and between about18 milliliters to about 20 milliliters.

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the valvedconduit (5) having a configuration capable of removably coupling to thefluid flow generator (2) and the earpiece (3). As to particularembodiments, the method can further include providing the valved conduit(5) having a configuration capable of coupling in a first configuration(45) with the fluid flow generator (2) and the earpiece (3) tounidirectionally regulate the fluid flow (8) in a first direction (47)in the first fluid flow conduit (49). As to other particularembodiments, the method can further include providing the valved conduit(5) having a configuration capable of coupling in a second configuration(46) with the fluid flow generator (2) and the earpiece (3) tounidirectionally regulate the fluid flow (8) in a second direction (48)in the first fluid flow conduit (49).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the firstvalve (52) having a configuration capable of dividing the first fluidflow conduit (49) into a first portion (53) proximate a first fluid flowconduit first end (50) and a second portion (54) proximate a first fluidflow conduit second end (51), and further comprising providing a secondfluid flow conduit (55) having a configuration capable of fluidiclycoupling between the first portion (53) of the first fluid flow conduit(49) and the ambient pressure (11), and further comprising providing asecond valve (56) having a configuration capable of interrupting thesecond fluid flow conduit (55) to unidirectionally regulate the fluidflow (8) in the second fluid flow conduit (55).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the fluidflow generator (2) configured as a volumetrically adjustable element(13) having an internal volume (19), the volumetrically adjustableelement (13) having a deformed condition (20) which decreases theinternal volume (19) to generate the fluid flow (8) in the first fluidflow conduit (49), the first valve (52) unidirectionally regulating thefluid flow (8) to egress from the axial earpiece bore (4) of theearpiece (3). As to particular embodiments, the volumetricallyadjustable element (13) can return to a non-deformed condition (21)which increases the internal volume (19) to generate the fluid flow (8)in the second fluid flow conduit (55), the second valve (56)unidirectionally regulating the fluid flow (8) to ingress from theambient pressure (11) toward the volumetrically adjustable element (13),the first valve (52) interrupting the fluid flow (8) in the first fluidflow conduit (49) from the second portion (54) toward the first portion(53).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the fluidflow generator (2) configured as a volumetrically adjustable element(13) having an internal volume (19), the volumetrically adjustableelement (13) having a deformed condition (20) which decreases theinternal volume (19) to generate the fluid flow (8) in the second fluidflow conduit (55), the second valve (52) unidirectionally regulating thefluid flow (8) to egress from the second fluid flow conduit (55) towardthe ambient pressure (11). As to particular embodiments, thevolumetrically adjustable element (13) can return to a non-deformedcondition (21) which increases the internal volume (19) to generate thefluid flow (8) in the first fluid flow conduit (49), the first valve(52) unidirectionally regulating the fluid flow (8) to ingress from theaxial earpiece bore (4) of the earpiece (3) toward the volumetricallyadjustable element (13), the second valve (56) interrupting the fluidflow (8) in the second fluid flow conduit (55) from the ambient pressure(11) toward the first portion (53).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing a thirdfluid flow conduit (57) having a configuration capable of fluidiclycoupling between the second portion (54) of the first fluid flow conduit(49) and the ambient pressure (11), and further comprising providing athird valve (58) having a configuration capable of interrupting thethird fluid flow conduit (57) to unidirectionally regulate the fluidflow (8) in the third fluid flow conduit (57). As to particularembodiments, the method can further include providing the third valve(58) having a configuration capable of regulating the fluid flow (8) toegress to the ambient pressure (11). As to other particular embodiments,the method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the thirdvalve (58) having a configuration capable of regulating the fluid flow(8) to ingress from the ambient pressure (11).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the thirdvalve (58) having a configuration capable of interrupting the fluid flow(8) between the second portion (54) of the first fluid flow conduit (49)and the ambient pressure (11) until a pressure differential (9) betweenthe second portion (54) of the first fluid conduit (49) and the ambientpressure (11) exceeds a pre-selected pressure differential (9) having apressure differential amplitude (59) of between 0 kilopascals to about50 kilopascals. As to particular embodiments, the one or morepre-selected pressure differential amplitudes (59) can be selected fromthe group including or consisting of: between 0 kilopascals to about 5kilopascals, between about 2.5 kilopascals to about 7.5 kilopascals,between about 5 kilopascals to about 10 kilopascals, between about 7.5kilopascals to about 12.5 kilopascals, between about 10 kilopascals toabout 15 kilopascals, between about 12.5 kilopascals to about 17.5kilopascals, between about 15 kilopascals to about 20 kilopascals,between about 17.5 kilopascals to about 22.5 kilopascals, between about20 kilopascals to about 25 kilopascals, between about 22.5 kilopascalsto about 27.5 kilopascals, between about 25 kilopascals to about 30kilopascals, between about 27.5 kilopascals to about 32.5 kilopascals,between about 30 kilopascals to about 35 kilopascals, between about 32.5kilopascals to about 37.5 kilopascals, between about 35 kilopascals toabout 40 kilopascals, between about 37.5 kilopascals to about 42.5kilopascals, between about 40 kilopascals to about 45 kilopascals,between about 42.5 kilopascals to about 47.5 kilopascals, and betweenabout 45 kilopascals to about 50 kilopascals.

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing a secondvalve pressure relief element (71) having a configuration capable ofcoupling to the second valve (56) and a third valve pressure reliefelement (72) having a configuration capable of coupling to the thirdvalve (58), each one manually operable to correspondingly generate thefluid flow (8) in the second or third fluid flow conduits (55)(57).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the valvedconduit (5) having a configuration capable of coupling to the fluid flowgenerator (2) and the earpiece (3) in a first configuration (45) tounidirectionally regulate the fluid flow (8) in a first direction (47)in the first fluid flow conduit (49) to egress from the axial earpiecebore (4) of the earpiece (3). As to particular embodiments, the methodcan further include providing the fluid flow generator (2) configured asa volumetrically adjustable element (13) operable from a non-deformedcondition (21) toward a deformed condition (20) to generate the fluidflow (2) which egresses from the axial earpiece bore (4) over a timeperiod (76).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the fluidflow generator (2) having a configuration capable of repeated operationfrom the non-deformed condition (21) toward the deformed condition (20)to generate the fluid flow (8) having a pressure wave (78) including apressure wave amplitude (77) and a pressure wave frequency (79). As toparticular embodiments, the pressure wave frequency (79) can be in arange of between 0 Hertz to about 10 Hertz. As to particularembodiments, one or more pressure wave frequencies (79) can be selectedfrom the group including or consisting of: between 0 Hertz to about 1Hertz, between about 0.5 Hertz to about 1.5 Hertz, between about 1 Hertzto about 2 Hertz, between about 1.5 Hertz to about 2.5 Hertz, betweenabout 2 Hertz to about 3 Hertz, between about 2.5 Hertz to about 3.5Hertz, between about 3 Hertz to about 4 Hertz, between about 3.5 Hertzto about 4.5 Hertz, between about 4 Hertz to about 5 Hertz, betweenabout 4.5 Hertz to about 5.5 Hertz, between about 5 Hertz to about 6Hertz, between about 5.5 Hertz to about 6.5 Hertz, between about 6 Hertzto about 7 Hertz, between about 6.5 Hertz to about 7.5 Hertz, betweenabout 7 Hertz to about 8 Hertz, between about 7.5 Hertz to about 8.5Hertz, between about 8 Hertz to about 9 Hertz, between about 8.5 Hertzto about 9.5 Hertz, and between about 9 Hertz to about 10 Hertz.

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing a thirdvalve pressure relief element (72) having a configuration capable ofcoupling to the third valve (56), whereby the fluid flow generator (2)and the third valve pressure relief element (72) can be capable ofalternate repeated operation to generate the fluid flow (2) having thepressure wave (78) including the pressure wave amplitude (77) and thepressure wave frequency (79).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the valvedconduit (5) having a configuration capable of coupling to the fluid flowgenerator (2) and the earpiece (3) in a second configuration (46) tounidirectionally regulate the fluid flow (8) in a second direction (48)in the first fluid flow conduit (49) to ingress to the axial earpiecebore (4) of the earpiece (3). As to particular embodiments, the methodcan further include providing the fluid flow generator (2) configured asa volumetrically adjustable element (13) operable from a deformedcondition (20) toward a non-deformed condition (21) to generate thefluid flow (2) which ingresses from the axial earpiece bore (4) over atime period (76).

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing the fluidflow generator (2) having a configuration capable of repeated operationfrom the deformed condition (20) toward the non-deformed condition (21)to generate the fluid flow (8) having a pressure wave (78) including apressure wave amplitude (77) and a pressure wave frequency (79). As toparticular embodiments, the pressure wave frequency (79) can be in arange of between 0 Hertz to about 10 Hertz. As to particularembodiments, one or more pressure wave frequencies (79) can be selectedfrom the group including or consisting of: between 0 Hertz to about 1Hertz, between about 0.5 Hertz to about 1.5 Hertz, between about 1 Hertzto about 2 Hertz, between about 1.5 Hertz to about 2.5 Hertz, betweenabout 2 Hertz to about 3 Hertz, between about 2.5 Hertz to about 3.5Hertz, between about 3 Hertz to about 4 Hertz, between about 3.5 Hertzto about 4.5 Hertz, between about 4 Hertz to about 5 Hertz, betweenabout 4.5 Hertz to about 5.5 Hertz, between about 5 Hertz to about 6Hertz, between about 5.5 Hertz to about 6.5 Hertz, between about 6 Hertzto about 7 Hertz, between about 6.5 Hertz to about 7.5 Hertz, betweenabout 7 Hertz to about 8 Hertz, between about 7.5 Hertz to about 8.5Hertz, between about 8 Hertz to about 9 Hertz, between about 8.5 Hertzto about 9.5 Hertz, and between about 9 Hertz to about 10 Hertz.

The method of producing particular embodiments of the external ear canalpressure regulation device (1) can further include providing a thirdvalve pressure relief element (72) having a configuration capable ofcoupling to the third valve (56), whereby the fluid flow generator (2)and the third valve pressure relief element (72) can be capable ofalternate repeated operation to generate the fluid flow (2) having thepressure wave (78) including the pressure wave amplitude (77) and thepressure wave frequency (79).

As to particular embodiments, components of the external ear canalpressure regulation device (1) can be entirely formed of the samematerial, or alternatively, various components of the external ear canalpressure regulation device (1) can be formed from different materials.Additionally, as to particular embodiments, the external ear canalpressure regulation device (1) or components of the external ear canalpressure regulation device (1) can be produced from any of a widevariety of processes depending upon the application, such as pressmolding, injection molding, fabrication, machining, printing,three-dimensional printing, or the like, or combinations thereof, as onepiece or assembled from a plurality of pieces into an embodiment of theexternal ear canal pressure regulation device (1) or provided as aplurality of pieces for assembly into an embodiment of the external earcanal pressure regulation device (1).

Components of the external ear canal pressure regulation device (1) canbe produced from any of a wide variety of materials which can provide anembodiment of the external ear canal pressure regulation device (1)useful to generate and regulate a fluid flow (1). By way of non-limitingexample, the valved conduit (1) can be produced from a variety ofelastomeric compounds, plastic, plastic-like material, acrylic,polyamide, polyester, polypropylene, polyvinyl chloride-based materials,silicone-based materials, or the like, or combinations thereof.

A method of using a particular embodiment of the external ear canalpressure regulation device (1) can include obtaining the external earcanal pressure regulation (1) device including a fluid flow generator(2) which generates a fluid flow; a valved conduit (5) fluidicly coupledto the fluid flow generator (2), the valved conduit (5) having a firstfluid flow conduit (49) interruptible by a first valve (52) tounidirectionally regulate the fluid flow (8) in the first fluid flowconduit (49); and an earpiece (3) having an axial earpiece bore (4)which communicates between an earpiece first end (31) and an earpiecesecond end (29), the axial earpiece bore (4) fluidicly coupled to thevalved conduit (5) opposite the fluid flow generator (2), the earpiece(3) having a compliant earpiece external surface (7) configured tosealably engage an external ear canal (6) as a barrier between anexternal ear canal pressure (10) and an ambient pressure (11); sealablyengaging the earpiece external surface (7) of the earpiece (3) with theexternal ear canal (6); generating the fluid flow (8) between the fluidflow generator (2) and the axial earpiece bore (4); and regulating apressure differential (9) between the external ear canal pressure (10)and the ambient pressure (11).

As to particular embodiments, a method of using the external ear canalpressure regulation device (1) can include obtaining the external earcanal pressure regulation device (1) including a fluid flow generator(2) which generates a fluid flow (8); a valved conduit (5) having afirst fluid flow conduit (49) interruptible by a first valve (52) tounidirectionally regulate the fluid flow (8) in the first fluid flowconduit (49); and an earpiece (3) having an axial earpiece bore (4)which communicates between an earpiece first end (31) and an earpiecesecond end (29), the earpiece (3) having a compliant earpiece externalsurface (7) configured to sealably engage an external ear canal (6) as abarrier between an external ear canal pressure (10) and an ambientpressure (11); fluidicly coupling the valved conduit (5) in a firstconfiguration (45) with the fluid flow generator (2) and the axialearpiece bore (4) of the earpiece (3) to unidirectionally regulate thefluid flow (8) in a first direction (47) in the first fluid flow conduit(49); sealably engaging the earpiece external surface (7) of theearpiece (3) with the external ear canal (6); generating the fluid flow(8) between the fluid flow generator (2) and the axial earpiece bore (4)in the first direction (47) in the first fluid flow conduit (49); andregulating a pressure differential (9) between the external ear canalpressure (10) and the ambient pressure (11) wherein the external earcanal pressure (10) is greater than the ambient pressure (11).

As to particular embodiments, the method of using the external ear canalpressure regulation device (1) can further include operating a pressurerelief element (70) to generate the fluid flow (8) from the external earcanal (6) toward the ambient pressure (11) to return the external earcanal pressure (10) toward the ambient pressure (11). As to particularembodiments, the method can further include disengaging the earpieceexternal surface (7) of the earpiece (3) from the external ear canal(6).

As to particular embodiments, the method of using the external ear canalpressure regulation device (1) can further include uncoupling the valvedconduit (5) in the first configuration (45) from the fluid flowgenerator (2) and the axial earpiece bore (4) of the earpiece (3).

As to particular embodiments, the method of using the external ear canalpressure regulation device (1) can further include fluidicly couplingthe valved conduit (5) in a second configuration (46) with the fluidflow generator (2) and the axial earpiece bore (4) of the earpiece (3)to unidirectionally regulate the fluid flow (8) in a second direction(48) in the first fluid flow conduit (49); sealably engaging theearpiece external surface (7) of the earpiece (3) with the external earcanal (7); generating the fluid flow (8) between the fluid flowgenerator (2) and the axial earpiece bore (4) in the second direction(48) in the first fluid flow conduit (49); and regulating a pressuredifferential (9) between the external ear canal pressure (10) and theambient pressure (11) wherein the external ear canal pressure (10) islesser than the ambient pressure (11).

As to particular embodiments, the method of using the external ear canalpressure regulation device (1) can further include operating a pressurerelief element (70) to generate the fluid flow (8) from the ambientpressure (11) toward the external ear canal (6) to return the externalear canal pressure (10) toward the ambient pressure (11). As toparticular embodiments, the method can further include disengaging theearpiece external surface (7) of the earpiece (3) from the external earcanal (6).

As to particular embodiments, the method of using the external ear canalpressure regulation device (1) can further include uncoupling the valvedconduit (5) in the second configuration (46) from the fluid flowgenerator (2) and the axial earpiece bore (4) of the earpiece (3).

As can be easily understood from the foregoing, the basic concepts ofthe present invention may be embodied in a variety of ways. Theinvention involves numerous and varied embodiments of an external earcanal pressure regulation device and methods for making and using suchexternal ear canal pressure regulation devices including the best mode.

As such, the particular embodiments or elements of the inventiondisclosed by the description or shown in the figures or tablesaccompanying this application are not intended to be limiting, butrather exemplary of the numerous and varied embodiments genericallyencompassed by the invention or equivalents encompassed with respect toany particular element thereof. In addition, the specific description ofa single embodiment or element of the invention may not explicitlydescribe all embodiments or elements possible; many alternatives areimplicitly disclosed by the description and figures.

It should be understood that each element of an apparatus or each stepof a method may be described by an apparatus term or method term. Suchterms can be substituted where desired to make explicit the implicitlybroad coverage to which this invention is entitled. As but one example,it should be understood that all steps of a method may be disclosed asan action, a means for taking that action, or as an element which causesthat action. Similarly, each element of an apparatus may be disclosed asthe physical element or the action which that physical elementfacilitates. As but one example, the disclosure of a “fluid flow” shouldbe understood to encompass disclosure of the act of “flowingfluid”—whether explicitly discussed or not—and, conversely, were thereeffectively disclosure of the act of “flowing fluid”, such a disclosureshould be understood to encompass disclosure of a “fluid flow” and evena “means for flowing fluid.” Such alternative terms for each element orstep are to be understood to be explicitly included in the description.

In addition, as to each term used it should be understood that unlessits utilization in this application is inconsistent with suchinterpretation, common dictionary definitions should be understood to beincluded in the description for each term as contained in the RandomHouse Webster's Unabridged Dictionary, second edition, each definitionhereby incorporated by reference.

All numeric values herein are assumed to be modified by the term“about”, whether or not explicitly indicated. For the purposes of thepresent invention, ranges may be expressed as from “about” oneparticular value to “about” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueto the other particular value. The recitation of numerical ranges byendpoints includes all the numeric values subsumed within that range. Anumerical range of one to five includes for example the numeric values1, 1.5, 2, 2.75, 3, 3.80, 4, 5, and so forth. It will be furtherunderstood that the endpoints of each of the ranges are significant bothin relation to the other endpoint, and independently of the otherendpoint. When a value is expressed as an approximation by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. The term “about” generally refers to a rangeof numeric values that one of skill in the art would consider equivalentto the recited numeric value or having the same function or result.Similarly, the antecedent “substantially” means largely, but not wholly,the same form, manner or degree and the particular element will have arange of configurations as a person of ordinary skill in the art wouldconsider as having the same function or result. When a particularelement is expressed as an approximation by use of the antecedent“substantially,” it will be understood that the particular element formsanother embodiment.

Moreover, for the purposes of the present invention, the term “a” or“an” entity refers to one or more of that entity unless otherwiselimited. As such, the teens “a” or “an”, “one or more” and “at leastone” can be used interchangeably herein.

Thus, the applicant(s) should be understood to claim at least: i) eachof the external ear canal pressure regulation devices herein disclosedand described, ii) the related methods disclosed and described, iii)similar, equivalent, and even implicit variations of each of thesedevices and methods, iv) those alternative embodiments which accomplisheach of the functions shown, disclosed, or described, v) thosealternative designs and methods which accomplish each of the functionsshown as are implicit to accomplish that which is disclosed anddescribed, vi) each feature, component, and step shown as separate andindependent inventions, vii) the applications enhanced by the varioussystems or components disclosed, viii) the resulting products producedby such systems or components, ix) methods and apparatuses substantiallyas described hereinbefore and with reference to any of the accompanyingexamples, x) the various combinations and permutations of each of theprevious elements disclosed.

The background section of this patent application provides a statementof the field of endeavor to which the invention pertains. This sectionmay also incorporate or contain paraphrasing of certain United Statespatents, patent applications, publications, or subject matter of theclaimed invention useful in relating information, problems, or concernsabout the state of technology to which the invention is drawn toward. Itis not intended that any United States patent, patent application,publication, statement or other information cited or incorporated hereinbe interpreted, construed or deemed to be admitted as prior art withrespect to the invention.

The claims set forth in this specification, if any, are herebyincorporated by reference as part of this description of the invention,and the applicant expressly reserves the right to use all of or aportion of such incorporated content of such claims as additionaldescription to support any of or all of the claims or any element orcomponent thereof, and the applicant further expressly reserves theright to move any portion of or all of the incorporated content of suchclaims or any element or component thereof from the description into theclaims or vice-versa as necessary to define the matter for whichprotection is sought by this application or by any subsequentapplication or continuation, division, or continuation-in-partapplication thereof, or to obtain any benefit of, reduction in feespursuant to, or to comply with the patent laws, rules, or regulations ofany country or treaty, and such content incorporated by reference shallsurvive during the entire pendency of this application including anysubsequent continuation, division, or continuation-in-part applicationthereof or any reissue or extension thereon.

Additionally, the claims set forth in this specification, if any, arefurther intended to describe the metes and bounds of a limited number ofthe preferred embodiments of the invention and are not to be construedas the broadest embodiment of the invention or a complete listing ofembodiments of the invention that may be claimed. The applicant does notwaive any right to develop further claims based upon the description setforth above as a part of any continuation, division, orcontinuation-in-part, or similar application.

We claim:
 1. A method for treatment of a migraine headache, the methodcomprising: accessing an ear canal pressure regulation device thatcomprises: an earpiece for insertion into an external ear canal; and apressure regulator that defines a flow rate of fluid between theearpiece and ambient environment outside the ear; inserting the earpieceof the ear canal pressure regulation device into an external ear canalof a patient experiencing migraine headache pain, wherein the earpiecesealably engages the external ear canal as a barrier between an externalear canal pressure and ambient pressure; maintaining a seal between theearpiece and the external ear canal of the patient with a pressuredifferential between the external ear canal pressure and the ambientpressure; and permitting fluid to flow between the earpiece and theambient environment outside the ear at the flow rate defined by thepressure regulator without requiring user activation of the pressureregulator to reduce the pressure differential between the external earcanal pressure and the ambient pressure over a period of time such thatthe external ear canal pressure approaches the ambient pressure; whereinthe pressure differential between the external ear canal pressure andthe ambient pressure is effective to alleviate the migraine headachepain.
 2. The method of claim 1, wherein the earpiece comprises: a firstend; a second end that is smaller than the first end, wherein alongitudinal axis extends from the first end to the second end; anexternal surface that is tapered from the first end toward the secondend and that has a truncated cone shape; a plurality of circumferentialribs on the external surface of the earpiece, the plurality ofcircumferential ribs spaced apart between the first end and the secondend of the earpiece; and an axial earpiece bore extending along thelongitudinal axis between the first end and the second end of theearpiece.
 3. The method of claim 1, wherein the external ear canalpressure is higher than the ambient pressure to produce the pressuredifferential.
 4. The method of claim 1, wherein the external ear canalpressure is lower than the ambient pressure to produce the pressuredifferential.
 5. The method of claim 1, wherein fluid flow through thepressure regulator has the flow rate of about 0.2 milliliters per secondto about 20 millimeters per second.
 6. The method of claim 1, whereinthe pressure regulator comprises one or more valves.
 7. The method ofclaim 1, wherein the pressure regulator comprises a check valve.
 8. Themethod of claim 1, wherein the pressure regulator comprises a manualpressure release valve.
 9. The method of claim 1, wherein the ear canalpressure regulation device further comprising a fluid flow generator forgenerating a flow of fluid to increase the pressure differential betweenthe external ear canal pressure and the ambient pressure.
 10. The methodof claim 1, further comprising moving a tympanic membrane of the earusing the pressure differential between the external ear canal andambient pressure, wherein moving the tympanic membrane triggersmechanoreceptors to produce neural impulses that alleviate the migraineheadache pain.
 11. The method of claim 1, further comprising using theear canal pressure regulation device to increase and decrease thepressure differential between the external ear canal pressure and theambient pressure a plurality of times while the earpiece of the earcanal pressure regulation device is sealably engaged with the externalear canal.
 12. A method for treatment of a headache syndrome, the methodcomprising: inserting an ear canal pressure regulation device into anexternal ear canal of a patient, the ear canal pressure regulationdevice comprising: a fluid flow pathway to provide fluid communicationbetween the external ear canal and ambient environment outside the ear;and a pressure regulator that defines a flow rate of fluid through thefluid flow pathway; creating a seal between the ear canal pressureregulation device and the external ear canal as a barrier between anexternal ear canal pressure and ambient pressure; maintaining the sealbetween the ear canal pressure regulation device and the external earcanal while a pressure differential between the external ear canalpressure and the ambient pressure increases during a first period oftime; and maintaining the seal between the ear canal pressure regulationdevice and the external ear canal while the pressure differentialbetween the external ear canal pressure and the ambient pressuredecreases during a second period of time after the first period of time,wherein the pressure regulator automatically permits fluid to flow atthe flow rate through the fluid flow pathway to or from the ambientenvironment to decrease the pressure differential between the externalear canal pressure and the ambient pressure such that the external earcanal pressure approaches the ambient pressure; wherein the method iseffective to treat the headache syndrome.
 13. The method of claim 12,wherein the headache syndrome is a migraine headache.
 14. The method ofclaim 12, wherein the ear canal pressure regulation device comprises anearpiece for insertion into the external ear canal, the earpiece havinga truncated cone shape.
 15. The method of claim 14, wherein the earpiececomprises a plurality of circumferential ribs.
 16. The method of claim12, further comprising maintaining a constant pressure differentialbetween the external ear canal pressure and the ambient pressure for athird period of time between the first period of time and the secondperiod of time.
 17. The method of claim 12, wherein the external earcanal pressure is higher than the ambient pressure to produce thepressure differential.
 18. The method of claim 12, wherein the externalear canal pressure is lower than the ambient pressure to produce thepressure differential.
 19. The method of claim 12, wherein fluid flowthrough the pressure regulator has the flow rate of about 0.2milliliters per second to about 20 millimeters per second.
 20. Themethod of claim 12, wherein the pressure regulator comprises one or morevalves.
 21. The method of claim 12, wherein the pressure regulatorcomprises a check valve.
 22. The method of claim 12, wherein thepressure regulator comprises a manual pressure release valve.
 23. Themethod of claim 12, wherein the ear canal pressure regulation devicefurther comprising a fluid flow generator for generating a flow of fluidto increase the pressure differential between the external ear canalpressure and the ambient pressure.
 24. The method of claim 12, furthercomprising moving a tympanic membrane of the ear using the pressuredifferential between the external ear canal and ambient pressure,wherein moving the tympanic membrane triggers mechanoreceptors toproduce neural impulses that treat the headache syndrome.
 25. The methodof claim 12, further comprising using the ear canal pressure regulationdevice to increase and decrease the pressure differential between theexternal ear canal pressure and the ambient pressure a plurality oftimes while the ear canal pressure regulation device is inserted in theexternal ear canal.
 26. The method of claim 1, wherein the step ofpermitting fluid to flow comprises reducing the pressure differentialbetween the external ear canal pressure and the ambient pressure suchthat the external ear canal pressure reaches the ambient pressure. 27.The method of claim 12, wherein the pressure regulator permits fluid toflow through the fluid flow pathway to decrease the pressuredifferential between the external ear canal pressure and the ambientpressure such that the external ear canal pressure reaches the ambientpressure.